Cleared Traditional

K913505 - ENZYGNOST TOXOPLASMOSIS/IGM

K913505 is the FDA 510(k) clearance for ENZYGNOST TOXOPLASMOSIS/IGM by Behring Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K913505 · Behring Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
210d
Days
Class 2
Risk

K913505 is an FDA 510(k) clearance for the ENZYGNOST TOXOPLASMOSIS/IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 210 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K913505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1991
Decision Date March 04, 1992
Days to Decision 210 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
108d slower than avg
Panel avg: 102d · This submission: 210d
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 K913505.
BARTELS TOXOPLASMA IGM EIA
K922579 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS TOXOPLASMA IGG EIA
K922585 · Baxter Diagnostics, Inc. · Sep 1992
ENZYGNOST(R) TOXOPLASMOSIS/IGG
K913731 · Behring Diagnostics, Inc. · Apr 1992
TOXO IGG ELISA TEST (MODIFIED)
K915891 · Gull Laboratories, Inc. · Mar 1992
ELISA TOXO IGM
K914852 · Sclavo, Inc. · Jan 1992
TOXOPLASMA IGM ELISA TEST SYSTEM
K913787 · Zeus Scientific, Inc. · Dec 1991