Cleared Traditional

K955102 - BIODATA TESTOSTERONE MAIA KIT

K955102 is an FDA 510(k) clearance for BIODATA TESTOSTERONE MAIA KIT, manufactured by Biochem Immunosystems (U.S.), Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K955102

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 88d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

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 68
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K955102.
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
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K963080 · Bayer Corp. · Sep 1996
IMMULITE TOTAL TESTOSTERONE
K955870 · Diagnostic Products Corp. · Feb 1996
IMMULITE SHBG (MODIFICATION)
K955440 · Diagnostic Products Corp. · Dec 1995
AURAFLEX TESTOSTERONE CALIBRATOR PACK
K951685 · Organon Teknika Corp. · Nov 1995