Cleared Traditional

PREGNACOL PREGNANCY TEST (K972606) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972606 · Immunostics Inc., · Chemistry device
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Aug 1997
Decision
49d
Days
Class 2
Risk

K972606 is an FDA 510(k) clearance for the PREGNACOL PREGNANCY TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 49 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 Immunostics Inc., devices

Submission Details

510(k) Number K972606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date August 29, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 9
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K972606.
SAS(TM) DIRECT MONOCLONAL HCG
K935863 · Sa Scientific, Inc. · Feb 1994
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · Sa Scientific, Inc. · Mar 1993
PREGNOSPIA II
K881435 · Organon Teknika Corp. · May 1988
HCG-NOSTICK
K880328 · Organon Teknika Corp. · Mar 1988
TERUMO SENSIBEAD EIG HCG KIT
K854670 · Terumo Medical Corp. · Feb 1986
PREGNANCY CARD TEST
K852066 · Em Diagnostic Systems, Inc. · Jun 1985