Cleared Traditional

K852066 - PREGNANCY CARD TEST

K852066 is an FDA 510(k) clearance for PREGNANCY CARD TEST, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K852066 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
46d
Days
Class 2
Risk

K852066 is an FDA 510(k) clearance for the PREGNANCY CARD TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 46 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.

FDA 510(k) Submission Details - K852066

510(k) Number K852066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1985
Decision Date June 25, 1985
Days to Decision 46 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
43d faster than avg
Panel avg: 89d · This submission: 46d
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 94
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K852066.
TERUMO SENSIBEAD EIG HCG KIT
K854670 · Terumo Medical Corp. · Feb 1986
ACU-SLIDE-TEST
K853247 · Cal-Tech Diagnostics, Inc. · Sep 1985
DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST
K852286 · Sero-Immuno Diagnostics, Inc. · Jul 1985
PRECO PREGNANCY RAPID CARD TEST, HEM #2028
K850604 · Preco, Inc. · Apr 1985
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
K844346 · Fisher Diagnostics · Mar 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
K852066 · PREGNANCY CARD TEST
Download PDF Em Diagnostic Systems…