Cleared Traditional

ACCUTEX CRP LATEX TEST (K924332) - FDA 510(k) Clearance

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

K924332 · J.S. Medical Assoc. · Immunology device
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Dec 1992
Decision
102d
Days
Class 2
Risk

K924332 is an FDA 510(k) clearance for the ACCUTEX CRP LATEX TEST. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 102 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 K924332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date December 07, 1992
Days to Decision 102 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
2d faster than avg
Panel avg: 104d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 125
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