Cleared Traditional

K891393 - ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT

K891393 is an FDA 510(k) clearance for ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBOD..., manufactured by Orgenics, Ltd.. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K891393 · Orgenics, Ltd. · Microbiology device
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Jun 1989
Decision
101d
Days
Class 2
Risk

K891393 is an FDA 510(k) clearance for the ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Orgenics, Ltd. (Washington, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 101 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 Orgenics, Ltd. devices

FDA 510(k) Submission Details - K891393

510(k) Number K891393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1989
Decision Date June 23, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 102d · This submission: 101d
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 51
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K891393.
CMV IGM ELISA TEST SYSTEM
K896355 · Zeus Scientific, Inc. · Feb 1990
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230 · Gull Laboratories, Inc. · Dec 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610 · Organon Teknika Corp. · Jun 1989
CMV ELISA TEST SYSTEM
K891081 · Zeus Scientific, Inc. · Jun 1989
CMV-CUBE(TM)
K884842 · Difco Laboratories, Inc. · Apr 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248 · Disease Detection International, Inc. · Apr 1989