Cleared Traditional

K924259 - MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

K924259 is an FDA 510(k) clearance for MEDIX BIOTECH BESTEST(TM) HCG-URINE, manufactured by Medix Biotech, 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.

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

FDA 510(k) Submission Details - K924259

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.

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 288
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K924259.
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
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