Cleared Traditional

K843417 - CORDIA T-M

K843417 is an FDA 510(k) clearance for CORDIA T-M, manufactured by Cordis Corp.. The device is a Class 2 Immunology device with product code LGD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K843417 · Cordis Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
126d
Days
Class 2
Risk

K843417 is an FDA 510(k) clearance for the CORDIA T-M. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3780 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K843417

510(k) Number K843417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date January 04, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 104d · This submission: 126d
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 Immunology 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 K843417.
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
K862189 · Organon Teknika Corp. · Sep 1986
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
K860773 · Clinical Sciences, Inc. · May 1986
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · Abbott Laboratories · Jul 1985
AMIZYME-TOXOPLASMA GONDII KIT
K842528 · Amico Lab, Inc. · Sep 1984
TOXO-G EIA DIAGNOSTIC KIT
K840879 · Abbott Laboratories · May 1984