Cleared Traditional

K952319 - CONTRAST & RAPID HCG URINE/SERUM TST

K952319 is an FDA 510(k) clearance for CONTRAST & RAPID HCG URINE/SERUM TST, 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 33-day FDA review.

K952319 · Medix Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
33d
Days
Class 2
Risk

K952319 is an FDA 510(k) clearance for the CONTRAST & RAPID HCG URINE/SERUM TST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (San Carlos, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 33 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.

FDA 510(k) Submission Details - K952319

510(k) Number K952319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date June 20, 1995
Days to Decision 33 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
56d faster than avg
Panel avg: 89d · This submission: 33d
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 375
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K952319.
TESTPACK PLUS HCG URINE
K954029 · Abbott Laboratories · Oct 1995
MINISTRIP HCG
K951705 · International Newtech Development, Inc. · Oct 1995
WYNTEK OSOM HCG-URINE TEST
K953383 · Wyntek Diagnostics, Inc. · Aug 1995
BIONIKE A/Q PREGNANCY TEST
K951136 · Charlton Assoc. · Apr 1995
QUICK CHECKER HCG PREGNANCY TEST
K943859 · Mizuho USA, Inc. · Feb 1995
QUIKPAC II, ONE STEP HCG COMBO KIT
K945951 · Syntron Bioresearch, Inc. · Feb 1995
K952319 · CONTRAST & RAPID HCG URINE/SERUM TST
Download PDF FDA Summary Medix Biotech, Inc.