Cleared Traditional

K923925 - HCG STAT-PAK

K923925 is an FDA 510(k) clearance for HCG STAT-PAK, manufactured by Chembio Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K923925 · Chembio Diagnostic Systems, Inc. · Chemistry device
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Dec 1992
Decision
141d
Days
Class 2
Risk

K923925 is an FDA 510(k) clearance for the HCG STAT-PAK. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Chembio Diagnostic Systems, Inc. (Medford, US). The FDA issued a Cleared decision on December 24, 1992 after a review of 141 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 Chembio Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K923925

510(k) Number K923925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date December 24, 1992
Days to Decision 141 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
53d slower than avg
Panel avg: 88d · This submission: 141d
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 263
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K923925.
ACCESS TOTAL BHCG ASSAY
K926198 · Bio-Rad Laboratories, Inc. · Feb 1993
SAS ONE STEP PREGNANCY
K926204 · Sa Scientific, Inc. · Feb 1993
PRO-STEP HCG
K925125 · Disease Detection International, Inc. · Jan 1993
QUICKVUE ONE-STEP HCG TEST
K925435 · Quidel Corp. · Dec 1992
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259 · Medix Biotech, Inc. · Nov 1992
VISUAL HCG PREGNANCY TEST
K923376 · Tech-Co, Inc. · Oct 1992