Cleared Traditional

K881596 - FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-...

K881596 is the FDA 510(k) clearance for FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-... by Medix Biotech, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K881596 · Medix Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
45d
Days
Class 1
Risk

K881596 is an FDA 510(k) clearance for the FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 45 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K881596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1988
Decision Date May 27, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 46
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K881596.
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988
PHASE II FSH KIT
K883279 · Vitek Systems, Inc. · Sep 1988
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
K881142 · Amersham Corp. · Jul 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123 · Nichols Institute Diagnostics · Apr 1988
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · American Dade · Oct 1987
MICROMEDIC COMBOSTAT LH/FSH KIT
K872309 · Micromedic Systems · Jul 1987