Cleared Traditional

K852494 - CMV-IHA

K852494 is an FDA 510(k) clearance for CMV-IHA, manufactured by Hillcrest Biologicals. The device is a Class 2 Microbiology device with product code LJO cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K852494 · Hillcrest Biologicals · Microbiology device
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Sep 1985
Decision
96d
Days
Class 2
Risk

K852494 is an FDA 510(k) clearance for the CMV-IHA. Classified as Antigen, Iha, Cytomegalovirus (product code LJO), Class II - Special Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 96 days - within the typical 510(k) review window.

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 Hillcrest Biologicals devices

FDA 510(k) Submission Details - K852494

510(k) Number K852494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date September 16, 1985
Days to Decision 96 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
6d faster than avg
Panel avg: 102d · This submission: 96d
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 8
Devices cleared under the same product code (LJO) and FDA review panel - the closest regulatory comparables to K852494.
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
COPALIS CMV TOTAL ANTIBODY ASSAY
K955799 · Sienna Biotech, Inc. · Jul 1996
CMV LATEX AGGLUTINATION TEST KIT
K841520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984