Cleared Traditional

K893873 - SINGLE AND DUAL BAND DIPSTICK HCG TEST

K893873 is the FDA 510(k) clearance for SINGLE AND DUAL BAND DIPSTICK HCG TEST by Ampcor, Inc.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K893873 · Ampcor, Inc. · Chemistry device
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Aug 1989
Decision
87d
Days
Class 2
Risk

K893873 is an FDA 510(k) clearance for the SINGLE AND DUAL BAND DIPSTICK HCG TEST. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 87 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 Ampcor, Inc. devices

Submission Details

510(k) Number K893873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1989
Decision Date August 21, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 88d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHA System, Test, 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 - DHA System, Test, Human Chorionic Gonadotropin

All 45
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K893873.
SAS(TM) SERUM/URINE HCG
K932409 · Sa Scientific, Inc. · Jun 1993
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
K922073 · Baxter Diagnostics, Inc. · Oct 1992
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · Baxter Healthcare Corp · Aug 1991
STATUS HCG FLUOROMETRIC ENZYME
K893577 · Baxter Healthcare Corp · Aug 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · Leeco Diagnostics, Inc. · Jun 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · Leeco Diagnostics, Inc. · Jun 1989