Cleared Traditional

SHBG IRMA KIT (K861679) - FDA 510(k) Clearance

Class I Chemistry device.

K861679 · Farmos Group , Ltd. · Chemistry device
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Mar 1987
Decision
316d
Days
Class 1
Risk

K861679 is an FDA 510(k) clearance for the SHBG IRMA KIT. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Farmos Group , Ltd. (Washington, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Farmos Group , Ltd. devices

Submission Details

510(k) Number K861679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1986
Decision Date March 13, 1987
Days to Decision 316 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 88d · This submission: 316d
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 30
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K861679.
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IMMULITE SHBG
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K883267 · Diagnostic Products Corp. · Oct 1988
COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS
K844423 · Diagnostic Products Corp. · Feb 1985
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE
K831342 · Diagnostic Products Corp. · Jun 1983
COAT-A-COUNT TESTOSTERONE RIA KIT
K813401 · Diagnostic Products Corp. · Dec 1981