Cleared Traditional

K920917 - ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY

K920917 is an FDA 510(k) clearance for ELISA TUBE FSH TEST KIT ENZYME LINKED I..., manufactured by Bio Clinic Co.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K920917 · Bio Clinic Co. · Chemistry device
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Mar 1992
Decision
27d
Days
Class 1
Risk

K920917 is an FDA 510(k) clearance for the ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Bio Clinic Co. (St. Louis, US). The FDA issued a Cleared decision on March 26, 1992 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 Bio Clinic Co. devices

FDA 510(k) Submission Details - K920917

510(k) Number K920917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date March 26, 1992
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
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 - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 70
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K920917.
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