Cleared Traditional

ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 (K973448) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973448 · Beckman Instruments, Inc. · Microbiology device
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Sep 1998
Decision
371d
Days
Class 2
Risk

K973448 is an FDA 510(k) clearance for the ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 344.... Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on September 17, 1998 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K973448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1997
Decision Date September 17, 1998
Days to Decision 371 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
269d slower than avg
Panel avg: 102d · This submission: 371d
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 35
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K973448.
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
QUANTA LITE TOXOPLASMA IGG
K971441 · Inova Diagnostics, Inc. · Dec 1997
IMMULITE TOXOPLASMA QUANTITATIVE IGG
K962936 · Diagnostic Products Corp. · Apr 1997
AXSYM TOXO IGM
K954576 · Abbott Laboratories · Aug 1996