Cleared Traditional

K955141 - OSOM HCG COMBO TEST

K955141 is an FDA 510(k) clearance for OSOM HCG COMBO TEST, manufactured by Wyntek Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K955141 · Wyntek Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
23d
Days
Class 1
Risk

K955141 is an FDA 510(k) clearance for the OSOM HCG COMBO TEST. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Wyntek Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 - K955141

510(k) Number K955141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date December 06, 1995
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 422
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K955141.
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ACCESS LOW LEVEL IGE CONTROLS
K953883 · Bio-Rad Laboratories, Inc. · Nov 1995
OPUS HCG CONTROLS
K954144 · Behring Diagnostics, Inc. · Oct 1995
IMMULITE HCG HIGH LEVEL CONTROL MODULE
K952251 · Diagnostic Products Corp. · Sep 1995