Cleared Traditional

K852286 - DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST

K852286 is the FDA 510(k) clearance for DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST by Sero-Immuno Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K852286 · Sero-Immuno Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
41d
Days
Class 2
Risk

K852286 is an FDA 510(k) clearance for the DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Sero-Immuno Diagnostics, Inc. (Tucker, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 41 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 Sero-Immuno Diagnostics, Inc. devices

Submission Details

510(k) Number K852286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date July 09, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 K852286.
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · Leeco Diagnostics, Inc. · Jul 1986
DELFIA (TM) HCG KIT
K862044 · Lkb Instruments, Inc. · Jul 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