Cleared Traditional

K872942 - IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530

K872942 is an FDA 510(k) clearance for IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMB..., manufactured by Clinical Sciences, Inc.. The device is a Class 2 Microbiology device with product code LKQ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K872942 · Clinical Sciences, Inc. · Microbiology device
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Jan 1988
Decision
168d
Days
Class 2
Risk

K872942 is an FDA 510(k) clearance for the IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Whippany, US). The FDA issued a Cleared decision on January 11, 1988 after a review of 168 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 Clinical Sciences, Inc. devices

FDA 510(k) Submission Details - K872942

510(k) Number K872942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date January 11, 1988
Days to Decision 168 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
66d slower than avg
Panel avg: 102d · This submission: 168d
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 K872942.
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · Immuno Concepts, Inc. · Jul 1989
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
K893466 · Immuno Concepts, Inc. · Jul 1989
ABBOTT CMV-M EIA KIT
K872881 · Abbott Laboratories · May 1988
CMV IGM MICROASSAY
K871832 · Diamedix Corp. · Aug 1987
FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
K863798 · Whittaker Bioproducts, Inc. · Apr 1987
ENZYGNOST ANTI-CMV IGM TEST
K861363 · Behring Diagnostics, Inc. · Jul 1986