Cleared Traditional

K895461 - WELLCOLEX COLOUR SHIGELLA TEST ZC51

K895461 is an FDA 510(k) clearance for WELLCOLEX COLOUR SHIGELLA TEST ZC51, manufactured by Wellcome Diagnostics. The device is a Class 2 Microbiology device with product code GNB cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K895461 · Wellcome Diagnostics · Microbiology device
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Jan 1990
Decision
127d
Days
Class 2
Risk

K895461 is an FDA 510(k) clearance for the WELLCOLEX COLOUR SHIGELLA TEST ZC51. Classified as Antisera, All Types, Shigella Spp. (product code GNB), Class II - Special Controls.

Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wellcome Diagnostics devices

FDA 510(k) Submission Details - K895461

510(k) Number K895461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date January 11, 1990
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 102d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GNB Device Classification - Class 2, Special Controls

Product Code GNB Antisera, All Types, Shigella Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3660
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 - GNB Antisera, All Types, Shigella Spp.

All 40
Devices cleared under the same product code (GNB) and FDA review panel - the closest regulatory comparables to K895461.
SAS SHIGELLA BOYDII TYPE 6 ANTISERUM
K953327 · Sa Scientific, Inc. · Aug 1995
SAS SHIGELLA BOYDII TYPE 7 ANTISERUM
K953328 · Sa Scientific, Inc. · Aug 1995
SAS SHIGELLA BOYDII GROUP C2 ANTISERUM
K953329 · Sa Scientific, Inc. · Aug 1995
PHADEBACT SHIGELLA TEST
K880752 · Pharmacia, Inc. · Feb 1989
SHIGELLA I.D.
K821337 · Analytical Products, Inc. · May 1982