Cleared Traditional

EYE SPOT CRP TEST (K932180) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932180 · J.S. Medical Assoc. · Immunology device
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Aug 1993
Decision
110d
Days
Class 2
Risk

K932180 is an FDA 510(k) clearance for the EYE SPOT CRP TEST. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all J.S. Medical Assoc. devices

Submission Details

510(k) Number K932180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1993
Decision Date August 23, 1993
Days to Decision 110 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 104d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 69
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K932180.
CardioPhase® hsCRP
K232624 · Siemens Healthcare Diagnostic Products GmbH · Nov 2023
RCRP Flex reagent cartridge
K221119 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Tina-quant C-Reactive Protein IV
K192072 · Roche Diagnostics Operations (Rdo) · Feb 2020
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · The Binding Site Group , Ltd. · Oct 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · The Binding Site Group , Ltd. · Feb 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018