Cleared Traditional

K823871 - TANDEM-E -FER IMMUNOENZYMETRIC KIT

K823871 is the FDA 510(k) clearance for TANDEM-E -FER IMMUNOENZYMETRIC KIT by Hybritech, Inc.. It is a Class 2 Chemistry device (product code DBF) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K823871 · Hybritech, Inc. · Chemistry device
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Feb 1983
Decision
64d
Days
Class 2
Risk

K823871 is an FDA 510(k) clearance for the TANDEM-E -FER IMMUNOENZYMETRIC KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Hybritech, Inc. (Walker, US). The FDA issued a Cleared decision on February 25, 1983 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5340 - the FDA in vitro diagnostics and chemistry 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 Hybritech, Inc. devices

Submission Details

510(k) Number K823871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1982
Decision Date February 25, 1983
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 Chemistry devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 63
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K823871.
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K844158 · American Dade · Nov 1984
DSL FERRITIN IRMA
K841925 · Diagnostic Systems Laboratories, Inc. · May 1984
CORNING FERRITIN 125I RADIOIMMUNOASSAY
K830591 · Corning Medical & Scientific · Mar 1983
AUTOPAK FERRITIN TEST DELIVERY SYS
K823275 · Micromedic Systems · Dec 1982
ANTISERA TO HUMAN FERRITIN
K822472 · Kent Laboratories, Inc. · Sep 1982
FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS
K812786 · Corning Medical & Scientific · Oct 1981