Cleared Traditional

K893605 - SRI LUTEINIZING HORMONE IMMUNOENZYMETRI...

K893605 is the FDA 510(k) clearance for SRI LUTEINIZING HORMONE IMMUNOENZYMETRI... by Serono-Baker Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K893605 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Jun 1989
Decision
41d
Days
Class 1
Risk

K893605 is an FDA 510(k) clearance for the SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 41 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 Serono-Baker Diagnostics, Inc. devices

Submission Details

510(k) Number K893605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1989
Decision Date June 20, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 69
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K893605.
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K895094 · Hybritech, Inc. · Oct 1989
CLEARPLAN EASY
K894579 · Unipath , Ltd. · Oct 1989
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
COTUBE LH IRMA ASSAY
K884498 · Bio-Rad · Dec 1988