Cleared Traditional

K974901 - HYBRID CAPTURE SYSTEM CMV DNA ASSAY

K974901 is an FDA 510(k) clearance for HYBRID CAPTURE SYSTEM CMV DNA ASSAY, manufactured by Digene Corp.. The device is a Class 2 Microbiology device with product code LJO cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K974901 · Digene Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
272d
Days
Class 2
Risk

K974901 is an FDA 510(k) clearance for the HYBRID CAPTURE SYSTEM CMV DNA ASSAY. Classified as Antigen, Iha, Cytomegalovirus (product code LJO), Class II - Special Controls.

Submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on September 29, 1998 after a review of 272 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 Digene Corp. devices

FDA 510(k) Submission Details - K974901

510(k) Number K974901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1997
Decision Date September 29, 1998
Days to Decision 272 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 102d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJO Device Classification - Class 2, Special Controls

Product Code LJO Antigen, Iha, 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 - LJO Antigen, Iha, Cytomegalovirus

All 7
Devices cleared under the same product code (LJO) and FDA review panel - the closest regulatory comparables to K974901.
Capture-CMV
K203612 · Immucor, Inc. · Mar 2021
Capture-CMV
K183571 · Immucor, Inc. · Feb 2019
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · Diamedix Corp. · Aug 2000
CMVGEN
K974456 · Instrumentation Laboratory CO · May 1998
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K951851 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1996
CMV-IHA
K852494 · Hillcrest Biologicals · Sep 1985