Cleared Traditional

K800991 - CORDIA N

K800991 is an FDA 510(k) clearance for CORDIA N, manufactured by Cordis Corp.. The device is a Class 2 Immunology device with product code DHC cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800991 · Cordis Corp. · Immunology device
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May 1980
Decision
14d
Days
Class 2
Risk

K800991 is an FDA 510(k) clearance for the CORDIA N. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by Cordis Corp. (Walker, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K800991

510(k) Number K800991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1980
Decision Date May 08, 1980
Days to Decision 14 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
90d faster than avg
Panel avg: 104d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHC Device Classification - Class 2, Special Controls

Product Code DHC System, Test, Systemic Lupus Erythematosus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5820
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 - DHC System, Test, Systemic Lupus Erythematosus

All 11
Devices cleared under the same product code (DHC) and FDA review panel - the closest regulatory comparables to K800991.
IMMUNOWELL DSDNA ANTIBODY TEST
K914801 · General Biometrics, Inc. · Dec 1991
SERO/TEX LE TEST
K821385 · Texas Immunology, Inc. · May 1982
SLE ANTI-N-DNA LATEX TEST
K810226 · Icl Scientific · Feb 1981
CORDIA NP
K800992 · Cordis Corp. · May 1980
IIF-A-N-DNA TEST KIT
K790106 · Medica Corp. · Mar 1979
SYSTEMIC LUPUS
K790257 · Icl Scientific · Mar 1979