Cleared Traditional

K962341 - HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)

K962341 is an FDA 510(k) clearance for HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROG..., manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with product code JNL cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K962341 · Hycor Biomedical, Inc. · Immunology device
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Nov 1996
Decision
160d
Days
Class 2
Risk

K962341 is an FDA 510(k) clearance for the HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG). Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 160 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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 Hycor Biomedical, Inc. devices

FDA 510(k) Submission Details - K962341

510(k) Number K962341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1996
Decision Date November 25, 1996
Days to Decision 160 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 105d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JNL Device Classification - Class 2, Special Controls

Product Code JNL Immunochemical, Thyroglobulin Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 - JNL Immunochemical, Thyroglobulin Autoantibody

All 15
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K962341.
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · Phadia US, Inc. · Nov 2007
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · Monobind · Jul 1997
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · Hycor Biomedical, Inc. · Nov 1996
AURAFLEX TG-AB AND TPO-AB
K951320 · Organon Teknika Corp. · Aug 1995
AURAFLEX TPO-AB
K952607 · Organon Teknika Corp. · Aug 1995