Cleared Traditional

K953383 - WYNTEK OSOM HCG-URINE TEST

K953383 is an FDA 510(k) clearance for WYNTEK OSOM HCG-URINE TEST, manufactured by Wyntek Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K953383 · Wyntek Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
41d
Days
Class 2
Risk

K953383 is an FDA 510(k) clearance for the WYNTEK OSOM HCG-URINE TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Wyntek Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on August 29, 1995 after a review of 41 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.

View all Wyntek Diagnostics, Inc. devices

FDA 510(k) Submission Details - K953383

510(k) Number K953383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1995
Decision Date August 29, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 252
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K953383.
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732 · Bio-Rad Laboratories, Inc. · Nov 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273 · Quidel Corp. · Oct 1995
TESTPACK PLUS HCG URINE
K954029 · Abbott Laboratories · Oct 1995
CONTRAST & RAPID HCG URINE/SERUM TST
K952319 · Medix Biotech, Inc. · Jun 1995
QUIKPAC II, ONE STEP HCG COMBO KIT
K945951 · Syntron Bioresearch, Inc. · Feb 1995
RAPIDVUE(TM) HCG
K945969 · Quidel Corp. · Jan 1995