Cleared Traditional

K913505 - ENZYGNOST TOXOPLASMOSIS/IGM

K913505 is an FDA 510(k) clearance for ENZYGNOST TOXOPLASMOSIS/IGM, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K913505

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.

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 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