Cleared Traditional

K885344 - IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT

K885344 is an FDA 510(k) clearance for IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY ..., manufactured by Orgenics, Ltd.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K885344 · Orgenics, Ltd. · Microbiology device
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Apr 1989
Decision
105d
Days
Class 2
Risk

K885344 is an FDA 510(k) clearance for the IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Orgenics, Ltd. (Washington, US). The FDA issued a Cleared decision on April 12, 1989 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - 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 - K885344

510(k) Number K885344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date April 12, 1989
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 102d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGD Device Classification - Class 2, Special Controls

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
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 - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 96
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K885344.
TOXO ELISA TEST SYSTEM
K891781 · Zeus Scientific, Inc. · Jul 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · Abbott Laboratories · Jun 1989
IMX TOXO IGM ANTIBODY ASSAY
K890032 · Abbott Laboratories · Jun 1989
MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT
K884249 · Disease Detection International, Inc. · Apr 1989
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
K883937 · Ortho Diagnostic Systems, Inc. · Feb 1989
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
K890154 · Labsystems, Inc. · Feb 1989