Cleared Traditional

K890146 - WELLCOLEX COLOUR SALMONELLA TEST ZL 50

K890146 is the FDA 510(k) clearance for WELLCOLEX COLOUR SALMONELLA TEST ZL 50 by Wellcome Diagnostics. It is a Class 2 Microbiology device (product code GRM) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K890146 · Wellcome Diagnostics · Microbiology device
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Feb 1989
Decision
34d
Days
Class 2
Risk

K890146 is an FDA 510(k) clearance for the WELLCOLEX COLOUR SALMONELLA TEST ZL 50. Classified as Antisera, All Groups, Salmonella Spp. (product code GRM), Class II - Special Controls.

Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on February 16, 1989 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3550 - the FDA microbiology device 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 Wellcome Diagnostics devices

Submission Details

510(k) Number K890146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1989
Decision Date February 16, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GRM Antisera, All Groups, Salmonella Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3550
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 Microbiology devices follow this clearance model.

Regulatory Peers - GRM Antisera, All Groups, Salmonella Spp.

All 66
Devices cleared under the same product code (GRM) and FDA review panel - the closest regulatory comparables to K890146.
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