Cleared Traditional

K972884 - ACCURUN 146 CMV IGM POSITIVE CONTROL

K972884 is an FDA 510(k) clearance for ACCURUN 146 CMV IGM POSITIVE CONTROL, manufactured by Boston Biomedica, Inc.. The device is a Class 2 Microbiology device with product code LKQ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K972884 · Boston Biomedica, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
17d
Days
Class 2
Risk

K972884 is an FDA 510(k) clearance for the ACCURUN 146 CMV IGM POSITIVE CONTROL. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on August 22, 1997 after a review of 17 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 Boston Biomedica, Inc. devices

FDA 510(k) Submission Details - K972884

510(k) Number K972884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1997
Decision Date August 22, 1997
Days to Decision 17 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
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKQ Device Classification - Class 2, Special Controls

Product Code LKQ Antibody Igm,if, Cytomegalovirus Virus
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 - LKQ Antibody Igm,if, Cytomegalovirus Virus

All 15
Devices cleared under the same product code (LKQ) and FDA review panel - the closest regulatory comparables to K972884.
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
K100433 · Siemens Healthcare Diagnostics · May 2010
VIDAS CMV IGM ASSAY
K933549 · Biomerieux Vitek, Inc. · Aug 1994
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · Baxter Diagnostics, Inc. · Apr 1993
ELISA CMV IGM
K914789 · Sclavo, Inc. · Mar 1992
CMV-IGM IFA TEST SYSTEM
K900743 · Zeus Scientific, Inc. · Apr 1990
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · Immuno Concepts, Inc. · Jul 1989