Cleared Traditional

K880163 - PREGNANCY (HCG) CARD & LIQUID TEST

K880163 is the FDA 510(k) clearance for PREGNANCY (HCG) CARD & LIQUID TEST by Ampcor, Inc.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K880163 · Ampcor, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
125d
Days
Class 2
Risk

K880163 is an FDA 510(k) clearance for the PREGNANCY (HCG) CARD & LIQUID TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 17, 1988 after a review of 125 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 Ampcor, Inc. devices

Submission Details

510(k) Number K880163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date May 17, 1988
Days to Decision 125 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 88d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 43
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K880163.
DIRECT PREGNANCY TEST
K920716 · Tech-Co, Inc. · Mar 1992
CLEARVIEW HCG
K910946 · Unipath , Ltd. · Apr 1991
PREGNOSPIA II
K881435 · Organon Teknika Corp. · May 1988
HCG-NOSTICK
K880328 · Organon Teknika Corp. · Mar 1988
PREGNASLIDE
K863198 · Armkel, LLC · Sep 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · Leeco Diagnostics, Inc. · Jul 1986