Cleared Traditional

ABBOTT TESTPACK PLUS HCG URINE (K894408) - FDA 510(k) Clearance

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

K894408 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
50d
Days
Class 2
Risk

K894408 is an FDA 510(k) clearance for the ABBOTT TESTPACK PLUS HCG URINE. 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 5, 1989 after a review of 50 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 K894408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date September 05, 1989
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K894408.
COAT-A-COUNT (TM) HCG IRMA
K894941 · Diagnostic Products Corp. · Oct 1989
ORTHO RESULT PLUS/PREGNANCY
K894420 · Ortho Diagnostic Systems, Inc. · Oct 1989
IMX TOTAL B-HCG
K894182 · Abbott Laboratories · Sep 1989
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · Ciba Corning Diagnostics Corp. · Oct 1988
COTUBE HCG IRMA TEST
K882155 · Bio-Rad · Aug 1988
ABBOTT IMX HCG
K880070 · Abbott Laboratories · Mar 1988