Cleared Traditional

K893200 - DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST

K893200 is an FDA 510(k) clearance for DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K893200 · Gull Laboratories, Inc. · Microbiology device
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Dec 1989
Decision
236d
Days
Class 2
Risk

K893200 is an FDA 510(k) clearance for the DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 18, 1989 after a review of 236 days - an extended review cycle.

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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K893200

510(k) Number K893200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1989
Decision Date December 18, 1989
Days to Decision 236 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
134d slower than avg
Panel avg: 102d · This submission: 236d
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 K893200.
TOXO IGG ELISA TEST
K900354 · Gull Laboratories, Inc. · Apr 1990
PLATELIA TOXO IGM KIT
K894948 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
MODIFIED CAPTIA(R) TOXO-M
K900655 · Mercia Diagnostics , Ltd. · Mar 1990
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