Cleared Traditional

K894182 - IMX TOTAL B-HCG

K894182 is an FDA 510(k) clearance for IMX TOTAL B-HCG, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K894182 · Abbott Laboratories · Chemistry device
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Sep 1989
Decision
102d
Days
Class 2
Risk

K894182 is an FDA 510(k) clearance for the IMX TOTAL B-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 September 26, 1989 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K894182

510(k) Number K894182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date September 26, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

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 218
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K894182.
QUIDEL HCG TEST
K894790 · Quidel Corp. · Oct 1989
COAT-A-COUNT (TM) HCG IRMA
K894941 · Diagnostic Products Corp. · Oct 1989
ORTHO RESULT PLUS/PREGNANCY
K894420 · Ortho Diagnostic Systems, Inc. · Oct 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · Abbott Laboratories · Sep 1989
HCG IRMA II
K891770 · Pacific Biotech, Inc. · May 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615 · Quidel Corp. · Apr 1989