Cleared Traditional

K001707 - DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST...

K001707 is the FDA 510(k) clearance for DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST... by Diamedix Corp.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K001707 · Diamedix Corp. · Microbiology device
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Jul 2000
Decision
32d
Days
Class 2
Risk

K001707 is an FDA 510(k) clearance for the DIAMEDIX IS-TOXOPLASMA IGM CAPTURE 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 July 7, 2000 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diamedix Corp. devices

Submission Details

510(k) Number K001707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2000
Decision Date July 07, 2000
Days to Decision 32 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
70d faster than avg
Panel avg: 102d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 73
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K001707.
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
K010755 · Bayer Corp. · Aug 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
K003259 · Beckman Coulter, Inc. · Jun 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
K002453 · Beckman Coulter, Inc. · Aug 2000
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
K993319 · bioMerieux, Inc. · May 2000
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