Cleared Traditional

K924259 - MEDIX BIOTECH BESTEST(TM) HCG-URINE

K924259 is the FDA 510(k) clearance for MEDIX BIOTECH BESTEST(TM) HCG-URINE by Medix Biotech, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K924259 · Medix Biotech, Inc. · Chemistry device
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Nov 1992
Decision
93d
Days
Class 2
Risk

K924259 is an FDA 510(k) clearance for the MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on November 25, 1992 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K924259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date November 25, 1992
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
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.

Device Classification

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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K924259.
ACCESS TOTAL BHCG ASSAY
K926198 · Bio-Rad Laboratories, Inc. · Feb 1993
SAS ONE STEP PREGNANCY
K926204 · Sa Scientific, Inc. · Feb 1993
QUICKVUE ONE-STEP HCG TEST
K925435 · Quidel Corp. · Dec 1992
VISUAL HCG PREGNANCY TEST
K923376 · Tech-Co, Inc. · Oct 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · Vitek Systems, Inc. · Jul 1992