Cleared Traditional

K894948 - PLATELIA TOXO IGM KIT

K894948 is the FDA 510(k) clearance for PLATELIA TOXO IGM KIT by Kallestad Diag, A Div. of Erbamont, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K894948 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology device
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Mar 1990
Decision
224d
Days
Class 2
Risk

K894948 is an FDA 510(k) clearance for the PLATELIA TOXO IGM KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 15, 1990 after a review of 224 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 Kallestad Diag, A Div. of Erbamont, Inc. devices

Submission Details

510(k) Number K894948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1989
Decision Date March 15, 1990
Days to Decision 224 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 102d · This submission: 224d
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 76
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K894948.
TOXO IGM ELISA TEST
K903324 · Gull Laboratories, Inc. · Oct 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
K900818 · Vitek Systems, Inc. · Apr 1990
TOXO IGG ELISA TEST
K900354 · Gull Laboratories, Inc. · Apr 1990
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST
K893200 · Gull Laboratories, Inc. · Dec 1989
TOXO ELISA TEST SYSTEM
K891781 · Zeus Scientific, Inc. · Jul 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · Abbott Laboratories · Jun 1989