Cleared Traditional

K951550 - CMV BRITE ANTIGENEMIA TEST KIT

K951550 is an FDA 510(k) clearance for CMV BRITE ANTIGENEMIA TEST KIT, manufactured by Biotest Diagnostics Corp.. The device is a Class 2 Microbiology device with product code LIN cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K951550 · Biotest Diagnostics Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
301d
Days
Class 2
Risk

K951550 is an FDA 510(k) clearance for the CMV BRITE ANTIGENEMIA TEST KIT. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Biotest Diagnostics Corp. (Denville, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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. Elevated predicate reliance profile. 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 Biotest Diagnostics Corp. devices

FDA 510(k) Submission Details - K951550

510(k) Number K951550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1995
Decision Date January 30, 1996
Days to Decision 301 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 102d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIN Device Classification - Class 2, Special Controls

Product Code LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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 - LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

All 14
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K951550.
NUCLISENS CMV PP67
K983762 · Organon Teknika Corp. · Sep 1999
CMV BRITE TURBO KIT
K991650 · Biotest Diagnostics Corp. · Jul 1999
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · Light Diagnostics · Jun 1996
PATHODX CYTOMEGALOVIRUS
K934798 · Diagnostic Products Corp. · Mar 1994
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · Incstar Corp. · Aug 1992
CMV-EA MAB TEST
K912592 · Gull Laboratories, Inc. · Dec 1991