Cleared Traditional

K850604 - PRECO PREGNANCY RAPID CARD TEST, HEM #2028

K850604 is an FDA 510(k) clearance for PRECO PREGNANCY RAPID CARD TEST, manufactured by Preco, Inc.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K850604 · Preco, Inc. · Chemistry device
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Apr 1985
Decision
52d
Days
Class 2
Risk

K850604 is an FDA 510(k) clearance for the PRECO PREGNANCY RAPID CARD TEST, HEM #2028. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Preco, Inc. (Oakland, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 52 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 Preco, Inc. devices

FDA 510(k) Submission Details - K850604

510(k) Number K850604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1985
Decision Date April 08, 1985
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K850604.
DIRECTACLONE CG SLIDE PREGNANCY TEST
K860945 · Pacific Biotech, Inc. · May 1986
TERUMO SENSIBEAD EIG HCG KIT
K854670 · Terumo Medical Corp. · Feb 1986
PREGNANCY CARD TEST
K852066 · Em Diagnostic Systems, Inc. · Jun 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · Stanbio Laboratory · Sep 1984
DUOCLON COLOR-CEPT
K842314 · Organon, Inc. · Aug 1984