Cleared Traditional

K921968 - IN VITRO DIAGNOSTIC REAGENT SET

K921968 is the FDA 510(k) clearance for IN VITRO DIAGNOSTIC REAGENT SET by Tech-Co, Inc.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 1523-day FDA review.

K921968 · Tech-Co, Inc. · Chemistry device
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Jun 1996
Decision
1523d
Days
Class 2
Risk

K921968 is an FDA 510(k) clearance for the IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Tech-Co, Inc. (Placentia, US). The FDA issued a Cleared decision on June 28, 1996 after a review of 1523 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Tech-Co, Inc. devices

Submission Details

510(k) Number K921968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date June 28, 1996
Days to Decision 1523 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1435d slower than avg
Panel avg: 88d · This submission: 1523d
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 42
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K921968.
SAS(TM) DIRECT MONOCLONAL HCG
K935863 · Sa Scientific, Inc. · Feb 1994
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · Sa Scientific, Inc. · Mar 1993
DIRECT PREGNANCY TEST
K920716 · Tech-Co, Inc. · Mar 1992
CLEARVIEW HCG
K910946 · Unipath , Ltd. · Apr 1991
PREGNOSPIA II
K881435 · Organon Teknika Corp. · May 1988
HCG-NOSTICK
K880328 · Organon Teknika Corp. · Mar 1988