Cleared Traditional

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (K002294) - FDA 510(k) Clearance

Class I Chemistry device.

K002294 · Biocheck, Inc. · Chemistry device
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Oct 2000
Decision
67d
Days
Class 1
Risk

K002294 is an FDA 510(k) clearance for the BIOCHECK TESTOSTERONE EIA, MODEL BC-1115. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on October 2, 2000 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biocheck, Inc. devices

Submission Details

510(k) Number K002294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2000
Decision Date October 02, 2000
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 88d · This submission: 67d
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.

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