Cleared Special

K993952 - IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6

K993952 is an FDA 510(k) clearance for IMMULITE 2000 CMV IGG, manufactured by Diagnostic Products Corp.. The device is a Class 2 Microbiology device with product code LFZ cleared through the Special 510(k) pathway after a 24-day FDA review.

K993952 · Diagnostic Products Corp. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
24d
Days
Class 2
Risk

K993952 is an FDA 510(k) clearance for the IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K993952

510(k) Number K993952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1999
Decision Date December 16, 1999
Days to Decision 24 days
Submission Type Special
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
78d faster than avg
Panel avg: 102d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

LFZ Device Classification - Class 2, Special Controls

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, 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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 57
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K993952.
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THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K984139 · Zeus Scientific, Inc. · Jan 1999
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983803 · Zeus Scientific, Inc. · Dec 1998
K993952 · IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
Download PDF FDA Summary Diagnostic Products C…