Cleared Traditional

K890610 - VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA...

K890610 is an FDA 510(k) clearance for VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA..., manufactured by Organon Teknika Corp.. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K890610 · Organon Teknika Corp. · Microbiology device
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Jun 1989
Decision
136d
Days
Class 2
Risk

K890610 is an FDA 510(k) clearance for the VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 136 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K890610

510(k) Number K890610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1989
Decision Date June 23, 1989
Days to Decision 136 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
34d slower than avg
Panel avg: 102d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 44
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K890610.
CMV IGG ELISA TEST
K900796 · Gull Laboratories, Inc. · May 1990
CMV IGM ELISA TEST SYSTEM
K896355 · Zeus Scientific, Inc. · Feb 1990
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230 · Gull Laboratories, Inc. · Dec 1989
CMV ELISA TEST SYSTEM
K891081 · Zeus Scientific, Inc. · Jun 1989
CMV-CUBE(TM)
K884842 · Difco Laboratories, Inc. · Apr 1989
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · Behring Diagnostics, Inc. · Sep 1985