Cleared Traditional

K874032 - IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1

K874032 is the FDA 510(k) clearance for IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1 by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K874032 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
89d
Days
Class 1
Risk

K874032 is an FDA 510(k) clearance for the IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 89 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K874032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1987
Decision Date December 30, 1987
Days to Decision 89 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
1d slower than avg
Panel avg: 88d · This submission: 89d
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 58
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K874032.
ABBOTT IMX LH
K884138 · Abbott Laboratories · Nov 1988
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
K880933 · Amersham Corp. · Jul 1988
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K881124 · Nichols Institute Diagnostics · Apr 1988
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