Cleared Traditional

K964633 - ACCUPACK PREGNANCY TEST

K964633 is an FDA 510(k) clearance for ACCUPACK PREGNANCY TEST, manufactured by Genix Biotek, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K964633 · Genix Biotek, Inc. · Chemistry device
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Feb 1997
Decision
93d
Days
Class 2
Risk

K964633 is an FDA 510(k) clearance for the ACCUPACK PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Genix Biotek, Inc. (San Diego, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 93 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 Genix Biotek, Inc. devices

FDA 510(k) Submission Details - K964633

510(k) Number K964633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1996
Decision Date February 20, 1997
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 251
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K964633.
ACCULINE PREGNANCY TEST
K971122 · Genix Biotek, Inc. · Apr 1997
CLINITEK HCG TEST STRIPS
K971209 · Bayer Corp. · Apr 1997
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
K970424 · Excel Scientific, Inc. · Mar 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · Abbott Laboratories · Feb 1997
SAS SERUM/URINE HCG
K965250 · Sascie · Feb 1997
SAS PREGNANCY STRIP
K965253 · Sascie · Feb 1997