Cleared Traditional

K880662 - VISION THYROXINE (T4)

K880662 is an FDA 510(k) clearance for VISION THYROXINE (T4), manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K880662 · Abbott Laboratories · Chemistry device
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Mar 1988
Decision
28d
Days
Class 2
Risk

K880662 is an FDA 510(k) clearance for the VISION(R) THYROXINE (T4). Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 16, 1988 after a review of 28 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.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K880662

510(k) Number K880662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1988
Decision Date March 16, 1988
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 59
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K880662.
MODIFIED CEDIA TOTAL T4 ASSAY
K884634 · Microgenics Corp. · Dec 1988
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K881357 · Syva Co. · May 1988
EMIT THYROXINE ASSAY
K880620 · Syva Co. · Mar 1988
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866 · Serono Diagnostics, Inc. · Feb 1988
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
K874603 · Ciba Corning Diagnostics Corp. · Dec 1987
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
K873976 · Amersham Corp. · Nov 1987