Cleared Special

K991650 - CMV BRITE TURBO KIT

K991650 is an FDA 510(k) clearance for CMV BRITE TURBO KIT, manufactured by Biotest Diagnostics Corp.. The device is a Class 2 Microbiology device with product code LIN cleared through the Special 510(k) pathway after a 60-day FDA review.

K991650 · Biotest Diagnostics Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
60d
Days
Class 2
Risk

K991650 is an FDA 510(k) clearance for the CMV BRITE TURBO 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 July 12, 1999 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biotest Diagnostics Corp. devices

FDA 510(k) Submission Details - K991650

510(k) Number K991650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1999
Decision Date July 12, 1999
Days to Decision 60 days
Submission Type Special
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
42d faster than avg
Panel avg: 102d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

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 K991650.
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · Diagnostic Hybrids, Inc. · Jun 2008
NUCLISENS CMV PP67
K983762 · Organon Teknika Corp. · Sep 1999
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · Light Diagnostics · Jun 1996
CMV BRITE ANTIGENEMIA TEST KIT
K951550 · Biotest Diagnostics Corp. · Jan 1996
PATHODX CYTOMEGALOVIRUS
K934798 · Diagnostic Products Corp. · Mar 1994
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · Incstar Corp. · Aug 1992