Cleared Traditional

K973583 - ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS

K973583 is an FDA 510(k) clearance for ACE THEOPHYLLINE REAGENT, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K973583 · Schiapparelli Biosystems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
51d
Days
Class 2
Risk

K973583 is an FDA 510(k) clearance for the ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3880 - the FDA toxicology 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 Schiapparelli Biosystems, Inc. devices

FDA 510(k) Submission Details - K973583

510(k) Number K973583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date November 12, 1997
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 87d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLS Device Classification - Class 2, Special Controls

Product Code KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 Toxicology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 61
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K973583.
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
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