Cleared Traditional

K945634 - IMX TOXO IGM

K945634 is an FDA 510(k) clearance for IMX TOXO IGM, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K945634 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
162d
Days
Class 2
Risk

K945634 is an FDA 510(k) clearance for the IMX(R) TOXO IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 27, 1995 after a review of 162 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K945634

510(k) Number K945634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1994
Decision Date April 27, 1995
Days to Decision 162 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
60d slower than avg
Panel avg: 102d · This submission: 162d
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 83
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K945634.
IMMULITE TOXOPLASMA GONDII IGG
K950671 · Diagnostic Products Corp. · Feb 1996
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · Bio-Rad Laboratories, Inc. · Dec 1995
IMX TOXO IGG
K951636 · Abbott Laboratories · Aug 1995
VIDAS TOXO COMPETITION (TXC) ASSAY
K931334 · Biomerieux Vitek, Inc. · Jun 1993
VIDAS TOXO IG6 ASSAY (TX6)
K922737 · Biomerieux Vitek, Inc. · May 1993
VIDAS TOXOPLASMA GONDII IGM ASSSAY
K923166 · Biomerieux Vitek, Inc. · Feb 1993