Cleared Traditional

K973448 - ACCESS TOXOPLASMA IGM REAGENTS ON THE A...

K973448 is an FDA 510(k) clearance for ACCESS TOXOPLASMA IGM REAGENTS ON THE A..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 371-day FDA review.

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

FDA 510(k) Submission Details - K973448

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.

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 81
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K973448.
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
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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
IS-TOXOPLASMA IGG TEST SYSTEM
K981498 · Diamedix Corp. · Aug 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