Cleared Traditional

LANCER L-INA ANTI-IGA (K791401) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K791401 · Sherwood Medical Co. · Immunology device
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Oct 1979
Decision
79d
Days
Class 2
Risk

K791401 is an FDA 510(k) clearance for the LANCER L-INA ANTI-IGA. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K791401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1979
Decision Date October 17, 1979
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 104d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CZP Iga, Antigen, Antiserum, Control

All 53
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K791401.
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K193525 · HORIBA ABX SAS · Jun 2020
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130 · Beckman Coulter, Inc. · Feb 2006
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · Roche Diagnostics Corp. · Mar 2004
N LATEX IGA
K024038 · Dade Behring, Inc. · Feb 2003
IGA
K983359 · Abbott Laboratories · Nov 1998
QUANTEX IGA
K962200 · Instrumentation Laboratory CO · Sep 1996