Cleared Traditional

K981498 - IS-TOXOPLASMA IGG TEST SYSTEM

K981498 is an FDA 510(k) clearance for IS-TOXOPLASMA IGG TEST SYSTEM, manufactured by Diamedix Corp.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K981498 · Diamedix Corp. · Microbiology device
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Aug 1998
Decision
116d
Days
Class 2
Risk

K981498 is an FDA 510(k) clearance for the IS-TOXOPLASMA IGG TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 116 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K981498

510(k) Number K981498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1998
Decision Date August 21, 1998
Days to Decision 116 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 102d · This submission: 116d
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 K981498.
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F
K984317 · Zeus Scientific, Inc. · Jan 1999
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM
K984170 · Zeus Scientific, Inc. · Jan 1999
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
K973448 · Beckman Instruments, Inc. · Sep 1998
QUANTA LITE TOXOPLASMA IGG
K971441 · Inova Diagnostics, Inc. · Dec 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K971989 · Bayer Corp. · Oct 1997
SERAQUEST TOXOPLASMA IGM
K971672 · Quest Intl., Inc. · Oct 1997