Cleared Traditional

K955102 - BIODATA TESTOSTERONE MAIA KIT

K955102 is the FDA 510(k) clearance for BIODATA TESTOSTERONE MAIA KIT by Biochem Immunosystems (U.S.), Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K955102 · Biochem Immunosystems (U.S.), Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
229d
Days
Class 1
Risk

K955102 is an FDA 510(k) clearance for the BIODATA TESTOSTERONE MAIA KIT. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Biochem Immunosystems (U.S.), Inc. (Allentown, US). The FDA issued a Cleared decision on June 24, 1996 after a review of 229 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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.

View all Biochem Immunosystems (U.S.), Inc. devices

Submission Details

510(k) Number K955102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1995
Decision Date June 24, 1996
Days to Decision 229 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 88d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
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 - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 54
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K955102.
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K955440 · Diagnostic Products Corp. · Dec 1995
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