Cleared Traditional

K873668 - MEDIX BIOTECH LH ENZYME IMMUNOASSAY TES...

K873668 is the FDA 510(k) clearance for MEDIX BIOTECH LH ENZYME IMMUNOASSAY TES... by Medix Biotech, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K873668 · Medix Biotech, Inc. · Chemistry device
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Oct 1987
Decision
27d
Days
Class 1
Risk

K873668 is an FDA 510(k) clearance for the MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on October 7, 1987 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 K873668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1987
Decision Date October 07, 1987
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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 - CEP Radioimmunoassay, Luteinizing Hormone

All 68
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K873668.
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K881124 · Nichols Institute Diagnostics · Apr 1988
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · Diagnostic Products Corp. · Dec 1987
O.P.T.(TM) OVULATION PREDICTION TEST
K870584 · Warner-Lambert Co. · Nov 1987
ANSWER OVULATION TEST KIT
K871241 · Armkel, LLC · Oct 1987
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K873052 · American Dade · Sep 1987
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K872131 · Hybritech, Inc. · Aug 1987