Clinical calculator summary
FDA K130010 reported ROR category interpreter
Clinical calculator summary
FDA K130010 reported ROR category interpreter
A strict lookup for a Prosigna ROR score already generated by the FDA-cleared nCounter Dx assay context.
Evidence-based context for fast calculator use
- Purpose:
- Display the exact K130010 risk-category row without recreating the assay or converting ROR into a recurrence percentage.
- Population:
- Female postmenopausal patients with HR-positive invasive breast carcinoma after standard surgery/locoregional treatment, with adjuvant endocrine therapy alone planned: N0 stage I-II or N1 stage II.
- Factors:
- Externally reported integer ROR 0-100, N0 versus 1-3 positive nodes, Exact FDA K130010 applicability context
- Reference:
- U.S. Food and Drug Administration. K130010 Substantial Equivalence Decision Summary. 2013.
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Prosigna FDA K130010 Reported ROR Risk-Category Interpreter
Clinical Context & Background
Enter the externally generated integer Risk of Recurrence (ROR) score and the nodal group printed in the supported FDA K130010 report context. Those are the only two entries that select a category-table row; the remaining intended-use requirements are shown as guidance instead of repeated form questions.
Use only for the FDA K130010 intended population: postmenopausal women with HR-positive invasive breast carcinoma after standard locoregional treatment, with endocrine therapy alone planned; N0 stage I-II or 1-3 positive nodes at stage II. This route does not calculate ROR, run the proprietary gene-expression algorithm, assign an intrinsic subtype, estimate an individual recurrence percentage, predict treatment response or benefit, or select treatment.
Formula Logic
FDA K130010 reported-score lookup: N0 0-40 Low, 41-60 Intermediate, 61-100 High; N1 (1-3 positive nodes) 0-40 Low, 41-100 High.Reference Data
| Nodal status | Reported integer ROR | FDA K130010 category |
|---|---|---|
| Node negative (N0) | 0-40 | Low |
| Node negative (N0) | 41-60 | Intermediate |
| Node negative (N0) | 61-100 | High |
| Node positive (1-3) | 0-40 | Low |
| Node positive (1-3) | 41-100 | High |
Clinical Workflow
Use, Interpret, And Continue The Patient Pathway
Expand for workflow guidance, limitations, examples, and related next steps.
Clinical Workflow
Use, Interpret, And Continue The Patient Pathway
Expand for workflow guidance, limitations, examples, and related next steps.
When To Use
- Only when an external report provides an integer Prosigna ROR score generated in the FDA K130010 nCounter Dx assay context.
- Only for the K130010 intended population: postmenopausal female, HR-positive invasive breast carcinoma after standard locoregional treatment, with endocrine therapy alone planned.
How To Interpret
- For N0 stage I-II: 0-40 Low, 41-60 Intermediate, and 61-100 High.
- For N1 stage II with 1-3 positive nodes: 0-40 Low and 41-100 High; K130010 has no N1 Intermediate category.
- ROR is an assay score, not a percentage or a patient-specific recurrence probability.
What To Do Next
- Use the original assay report and integrate its result with clinicopathological factors and current clinical guidance outside this interpreter.
Limitations
- Does not calculate ROR, molecular subtype, gene expression, recurrence percentage, treatment response, treatment benefit, or treatment choice.
- Does not apply the broader 2023 international IFU or current US LDT criteria and does not combine their thresholds with K130010.
- N4+, premenopausal, HR-negative, noninvasive/other disease, wrong stage-node combinations, non-K130010 assay context, other timing, or other treatment context are outside scope.
- HER2-negative status was not an explicit K130010 intended-use requirement. HER2-positive or unknown status does not block this table lookup, but current-use eligibility must be confirmed from the actual assay report and current local testing context.
Validated Population
FDA K130010 intended-use population and category table only.
Calculation verification history
Verified
Calculation verification history
Verified: Production browser revalidation
- Three source-backed Prosigna cases passed through visible production controls across N0 ROR 40, N0 ROR 41, and N1 ROR 41.
- No unexpected N/A, literal undefined value, stale control, unsupported risk gauge, or browser-console error was observed.
Case-level evidence is retained in validation/browser-revalidation/prosigna-pam50-breast-cancer-test-2026-08-03.json.
: Production browser validation
- Ten source-backed cases were exercised on the public production route through visible browser controls; 10/10 case records passed their expected-versus-observed assertions across 11 visible submissions.
- Overall browser status: failed-console. medium: Production emitted minified React error #418 during the route load.
- Case-level inputs, expected and observed results, reset/repeat behavior, failure reproductions, and console evidence are retained in the production-browser evidence record.
Case-level production evidence is retained in validation/browser-production/prosigna-pam50-breast-cancer-test.json.
: Input workflow simplified and revalidated
- Reduced the public form to result-, branch-, unit-, and applicability-changing inputs; removed or consolidated non-scoring, administrative, and duplicate questions.
- Preserved the verified calculation or report-interpretation logic, thresholds, model version, component logic, and supported result pathways behind strict deterministic adapters.
- Passed the calculator-specific regression audit, adapter-parity and malformed-input checks, the 144-calculator input-quality audit, and the 43-calculator entry-burden audit.
: Full validation test
- 518/518 independently expected source, score-node, equality, malformed-input, applicability, wording, trace, UI, immutability, registry, inventory, report, history, and mirror assertions passed with zero category mismatch.
- This is source-to-code implementation verification, not independent clinical validation, individualized recurrence prediction, or treatment guidance.
: Correction
- Locked the permanent route to the FDA K130010 reported ROR category table and separated the broader 2023 international IFU and current US LDT context.
- Corrected N1 to 0-40 Low and 41-100 High, removed the fabricated N1 Intermediate category and recurrence-percentage labels, and preserved exact integer boundaries including score zero.
- Removed N0 defaults, Number coercion, malformed and decimal fallthrough, subtype and treatment claims, and added exact applicability, source, trace, version, reset, and immutability safeguards.
Included in the current validation report.
Verification confirms the calculator implementation against the cited model; it is not independent clinical validation, regulatory approval, or medical advice.
Related Tools
Frequently Asked Questions
When should Prosigna FDA K130010 Reported ROR Risk-Category Interpreter be used?
Use it for patients undergoing breast cancer risk, staging, pathology, recurrence, or treatment-benefit assessment when all required inputs and the intended clinical setting are confirmed.
Can Prosigna FDA K130010 Reported ROR Risk-Category Interpreter determine treatment by itself?
No. Interpret the result with the cited evidence, complete clinical assessment, current guidelines, and patient-specific goals.
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