Cleared Traditional

K861212 - DIRECT ACU-SLIDE TEST

K861212 is the FDA 510(k) clearance for DIRECT ACU-SLIDE TEST by Cal-Tech Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K861212 · Cal-Tech Diagnostics, Inc. · Chemistry device
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Jul 1986
Decision
98d
Days
Class 2
Risk

K861212 is an FDA 510(k) clearance for the DIRECT ACU-SLIDE TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Cal-Tech Diagnostics, Inc. (Monterey Park, US). The FDA issued a Cleared decision on July 7, 1986 after a review of 98 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 Cal-Tech Diagnostics, Inc. devices

Submission Details

510(k) Number K861212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date July 07, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
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 K861212.
PREGNASLIDE
K863198 · Armkel, LLC · Sep 1986
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