Cleared Traditional

K894279 - LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST

K894279 is an FDA 510(k) clearance for LUTEINIZING HORMONE MAB SOLID PHASE COM..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K894279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Aug 1989
Decision
53d
Days
Class 1
Risk

K894279 is an FDA 510(k) clearance for the LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 53 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K894279

510(k) Number K894279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1989
Decision Date August 15, 1989
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

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 101
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K894279.
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K895094 · Hybritech, Inc. · Oct 1989
CLEARPLAN EASY
K894579 · Unipath , Ltd. · Oct 1989
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
K893605 · Serono-Baker Diagnostics, Inc. · Jun 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · Abbott Laboratories · Mar 1989
DELFIA HLH SPEC KIT
K883814 · Pharmacia, Inc. · Mar 1989