Cleared Traditional

K981377 - ACE T4 REAGENT T4 CALIBRATORS

K981377 is an FDA 510(k) clearance for ACE T4 REAGENT T4 CALIBRATORS, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K981377 · Schiapparelli Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
55d
Days
Class 2
Risk

K981377 is an FDA 510(k) clearance for the ACE T4 REAGENT T4 CALIBRATORS. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on June 10, 1998 after a review of 55 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 Schiapparelli Biosystems, Inc. devices

FDA 510(k) Submission Details - K981377

510(k) Number K981377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1998
Decision Date June 10, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
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 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K981377.
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
K991432 · Biocheck, Inc. · Jun 1999
OPTICOAT T4 EIA KIT
K982298 · Biotecx Laboratories, Inc. · Feb 1999
ABBOTT ARCHITECT TOTAL T4
K983440 · Abbott Laboratories · Nov 1998
ACCUWELL T4-EIA
K972974 · Neometrics, Inc. · Oct 1997
TOTAL THROXINE MICROPLATE EIA(225-300)
K971709 · Monobind · Jun 1997
DSL ACTIVE T4 EIA
K971269 · Diagnostic Systems Laboratories, Inc. · May 1997