Cleared Traditional

K944867 - TOXOSTAT

K944867 is an FDA 510(k) clearance for TOXOSTAT, manufactured by Bio-Whittaker, Inc., A Cambrex Co.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 595-day FDA review.

K944867 · Bio-Whittaker, Inc., A Cambrex Co. · Microbiology device
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May 1996
Decision
595d
Days
Class 2
Risk

K944867 is an FDA 510(k) clearance for the TOXOSTAT. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bio-Whittaker, Inc., A Cambrex Co. (Walkersville, US). The FDA issued a Cleared decision on May 14, 1996 after a review of 595 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Bio-Whittaker, Inc., A Cambrex Co. devices

FDA 510(k) Submission Details - K944867

510(k) Number K944867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1994
Decision Date May 14, 1996
Days to Decision 595 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
493d slower than avg
Panel avg: 102d · This submission: 595d
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 K944867.
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · Abbott Laboratories · Aug 1996
TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
K955760 · Bayer Corp. · Aug 1996
SERAQUEST TOXOPLASMA IGG
K960092 · Quest Intl., Inc. · Jun 1996
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