Cleared Traditional

K875363 - SERODOT TOXOPLASMA IGG TEST KIT

K875363 is an FDA 510(k) clearance for SERODOT TOXOPLASMA IGG TEST KIT, manufactured by Disease Detection International, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K875363 · Disease Detection International, Inc. · Microbiology device
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Apr 1988
Decision
112d
Days
Class 2
Risk

K875363 is an FDA 510(k) clearance for the SERODOT TOXOPLASMA IGG TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 112 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 Disease Detection International, Inc. devices

FDA 510(k) Submission Details - K875363

510(k) Number K875363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1987
Decision Date April 21, 1988
Days to Decision 112 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
10d slower than avg
Panel avg: 102d · This submission: 112d
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 94
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K875363.
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
BIOTROL TOXO ELISA TEST M
K873293 · Biotrol, USA, Inc. · Apr 1988
BIOTROL TOXO ELISA TEST G
K873294 · Biotrol, USA, Inc. · Apr 1988
TOXOSTAT M TEST KIT
K875113 · Whittaker Bioproducts, Inc. · Apr 1988