Cleared Traditional

K896982 - AIA-PACK T4

K896982 is an FDA 510(k) clearance for AIA-PACK T4, manufactured by Tosoh Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K896982 · Tosoh Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 1990
Decision
80d
Days
Class 2
Risk

K896982 is an FDA 510(k) clearance for the AIA-PACK T4. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Tosoh Corp. (Washington, D.C., US). The FDA issued a Cleared decision on March 9, 1990 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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.

FDA 510(k) Submission Details - K896982

510(k) Number K896982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1989
Decision Date March 09, 1990
Days to Decision 80 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
9d faster than avg
Panel avg: 89d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K896982.
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
OPUS T4 TEST SYSTEM
K897193 · Pb Diagnostic Systems, Inc. · Mar 1990
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
K897144 · Medix Biotech, Inc. · Mar 1990
VITRO T4-EIA-XT
K896865 · In Vitro Diagnostics, Inc. · Jan 1990
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
K896329 · Photec Diagnostics, Inc. · Dec 1989
T4 CLASP-BEAD EIA KIT
K892853 · Biotecx Laboratories, Inc. · May 1989
K896982 · AIA-PACK T4
Download PDF Tosoh Corp.