Cleared Traditional

K881932 - ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

K881932 is an FDA 510(k) clearance for ORTHO* CYTOMEGALOVIRUS IDENTIFICATION R..., manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code GQH cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K881932 · Ortho Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
83d
Days
Class 2
Risk

K881932 is an FDA 510(k) clearance for the ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on August 1, 1988 after a review of 83 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. 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K881932

510(k) Number K881932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1988
Decision Date August 01, 1988
Days to Decision 83 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
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQH Device Classification - Class 2, Special Controls

Product Code GQH Antigen, Cf (including Cf Control), 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 - GQH Antigen, Cf (including Cf Control), Cytomegalovirus

All 11
Devices cleared under the same product code (GQH) and FDA review panel - the closest regulatory comparables to K881932.
CMV ANTIGEN CONTROL SLIDES
K964875 · Viral Antigens, Inc. · Mar 1997
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
K935809 · Light Diagnostics · May 1994
FITC MURINE MONOCLONAL ANTI-CMV IGG
K882024 · Whittaker Bioproducts, Inc. · Aug 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290 · Syva Co. · Apr 1988
CYTOMEGALOVIRUS CONTROL SLIDES
K873114 · Medical Diagnostic Technologies, Inc. · Sep 1987
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
K864565 · Serono Diagnostics, Inc. · Feb 1987