Cleared Traditional

K961432 - RADIAS GALT TEST

K961432 is the FDA 510(k) clearance for RADIAS GALT TEST by Bio-Rad. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K961432 · Bio-Rad · Chemistry device
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Oct 1996
Decision
196d
Days
Class 1
Risk

K961432 is an FDA 510(k) clearance for the RADIAS GALT TEST. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 196 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K961432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date October 28, 1996
Days to Decision 196 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 88d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K961432.
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K963165 · Boehringer Mannheim Corp. · Aug 1996
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
K962975 · Diagnostic Products Corp. · Aug 1996