Cleared Traditional

K884138 - ABBOTT IMX LH

K884138 is an FDA 510(k) clearance for ABBOTT IMX LH, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K884138 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
60d
Days
Class 1
Risk

K884138 is an FDA 510(k) clearance for the ABBOTT IMX LH. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 60 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K884138

510(k) Number K884138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date November 29, 1988
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
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 85
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K884138.
DELFIA HLH SPEC KIT
K883814 · Pharmacia, Inc. · Mar 1989
COTUBE LH IRMA ASSAY
K884498 · Bio-Rad · Dec 1988
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
K883530 · Tambrands, Inc. · Dec 1988
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
K882340 · Serono Diagnostics, Inc. · Aug 1988
PHASE II LH KIT
K882252 · Vitek Systems, Inc. · Aug 1988
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
K880933 · Amersham Corp. · Jul 1988