Predicate Research & 510k Strategy Toolkit
510k database search protocol, predicate evaluation matrix, FDA-format comparison table, split predicate justification, performance standard comparison, and predicate strategy memo — find the strongest predicate and document it at FDA's standard.
What You Get
510k Database Systematic Search Protocol
Step-by-step protocol for conducting a systematic 510k database search to identify predicate candidates. Covers FDA 510k database search strategies (product code, panel, device class, regulation number), the CDRH summary database, search term selection, and the documentation format that demonstrates a thorough predicate search process to FDA reviewers who may question your predicate selection.
Predicate Device Candidate Evaluation Matrix
Structured matrix for evaluating 510k clearances identified in your predicate search against your device's intended use and technological characteristics. Covers clearance date currency, intended use comparison, device description comparison, performance standards, and the initial candidacy scoring criteria that narrow a broad search to the strongest predicate candidates for detailed comparison.
Predicate Comparison Table Template (FDA Format)
Side-by-side predicate comparison table in FDA's preferred format. Covers intended use comparison, indication for use comparison, technological characteristics comparison (with substantial equivalence argument for differences), and performance specification comparison. Structured to generate the predicate comparison section of the 510k submission directly from the completed template.
Split Predicate Justification Template
Documentation template for split predicate submissions where no single device provides both intended use and technological characteristics basis for substantial equivalence. Covers split predicate rationale, predicate 1 intended use basis, predicate 2 technological characteristics basis, and the FDA guidance citations that support the split predicate approach for your device type.
Predicate Device Performance Standard Comparison Worksheet
Worksheet for comparing performance specifications between your device and the predicate. Covers measurement methodology comparison, test standard applicability, acceptable performance range justification, and the performance differences analysis that determines whether a difference raises new questions of safety and effectiveness (the trigger for a not substantially equivalent determination).
510k Predicate Strategy Memo Template
Internal strategy memo template for documenting and defending predicate selection decisions. Covers predicate search summary, candidate evaluation rationale, final predicate selection justification, split predicate analysis if applicable, and the risk assessment for predicate-related NSE risk. Designed as the internal document that supports the 510k submission predicate section.
FAQ
How many predicates can I use in a 510k?
You can use multiple predicates. A split predicate approach uses one predicate for intended use and another for technological characteristics when no single device provides both. Additional predicates can support individual performance claims. Document your predicate selection rationale thoroughly.
Can I use a predicate that received a Not Substantially Equivalent (NSE) determination?
No. Only devices that received a substantially equivalent (SE) determination, cleared via 510k, De Novo, or that were legally marketed before May 28, 1976 (preamendments devices) can serve as predicates.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use in your 510k submission package.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal