Cleared Traditional

K883937 - ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST

K883937 is an FDA 510(k) clearance for ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K883937 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Feb 1989
Decision
141d
Days
Class 2
Risk

K883937 is an FDA 510(k) clearance for the ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 141 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K883937

510(k) Number K883937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1988
Decision Date February 07, 1989
Days to Decision 141 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
39d slower than avg
Panel avg: 102d · This submission: 141d
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 95
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K883937.
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
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
K890154 · Labsystems, Inc. · Feb 1989
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · Ortho Diagnostic Systems, Inc. · Oct 1988
CAPTIA TOXO-G
K880918 · Mercia Diagnostics , Ltd. · Aug 1988