Cleared Traditional

K982311 - BARTELS CINAKIT CMV ANTIGENEMIA

K982311 is an FDA 510(k) clearance for BARTELS CINAKIT CMV ANTIGENEMIA, manufactured by Intracel Corp.. The device is a Class 2 Microbiology device with product code GQH cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K982311 · Intracel Corp. · Microbiology device
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Dec 1998
Decision
166d
Days
Class 2
Risk

K982311 is an FDA 510(k) clearance for the BARTELS CINAKIT CMV ANTIGENEMIA. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on December 14, 1998 after a review of 166 days - an extended review 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: 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 Intracel Corp. devices

FDA 510(k) Submission Details - K982311

510(k) Number K982311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date December 14, 1998
Days to Decision 166 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
64d slower than avg
Panel avg: 102d · This submission: 166d
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 K982311.
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
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932 · Ortho Diagnostic Systems, Inc. · Aug 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290 · Syva Co. · Apr 1988
CYTOMEGALOVIRUS CONTROL SLIDES
K873114 · Medical Diagnostic Technologies, Inc. · Sep 1987