Cleared Traditional

K884498 - COTUBE LH IRMA ASSAY

K884498 is the FDA 510(k) clearance for COTUBE LH IRMA ASSAY by Bio-Rad. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K884498 · Bio-Rad · Chemistry device
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Dec 1988
Decision
57d
Days
Class 1
Risk

K884498 is an FDA 510(k) clearance for the COTUBE LH IRMA ASSAY. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 57 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 Bio-Rad devices

Submission Details

510(k) Number K884498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1988
Decision Date December 22, 1988
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
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 67
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K884498.
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · Abbott Laboratories · Mar 1989
DELFIA HLH SPEC KIT
K883814 · Pharmacia, Inc. · Mar 1989
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
K883530 · Tambrands, Inc. · Dec 1988
ABBOTT IMX LH
K884138 · Abbott Laboratories · Nov 1988
PHASE II LH KIT
K882252 · Vitek Systems, Inc. · Aug 1988