Cleared Traditional

K801281 - J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI

K801281 is the FDA 510(k) clearance for J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI by J.T. Baker Chemical Co.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K801281 · J.T. Baker Chemical Co. · Immunology device
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Jun 1980
Decision
22d
Days
Class 2
Risk

K801281 is an FDA 510(k) clearance for the J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1980 after a review of 22 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 J.T. Baker Chemical Co. devices

Submission Details

510(k) Number K801281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1980
Decision Date June 20, 1980
Days to Decision 22 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
82d faster than avg
Panel avg: 104d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, 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 - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K801281.
PHADEBAS IGG RAST TEST
K810694 · Pharmacia, Inc. · Jul 1981
AIM SYSTEM (FOR IGG)
K811126 · Icl Scientific · May 1981
IMMUNOLOGY CONTROL SERUM
K810056 · Icl Scientific · Feb 1981
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K800897 · Icl Scientific · May 1980
GEMENI IGG ASSAY
K800451 · Electro-Nucleonics Laboratories, Inc. · Apr 1980
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119 · Calbiochem-Behring Corp. · Feb 1980