Cleared Traditional

IMX HCG (K912534) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912534 · Abbott Laboratories · Chemistry device
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Jul 1991
Decision
24d
Days
Class 2
Risk

K912534 is an FDA 510(k) clearance for the IMX HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 1, 1991 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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

Submission Details

510(k) Number K912534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1991
Decision Date July 01, 1991
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 64
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K912534.
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505 · Eastman Kodak Company · Mar 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701 · Eastman Kodak Company · Jan 1992
IMX TOTAL B-HCG
K912535 · Abbott Laboratories · Jul 1991
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · Ciba Corning Diagnostics Corp. · Oct 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · Abbott Laboratories · Sep 1990