Cleared Traditional

K854183 - IN VITRO TEST DETERMINATION OF THEOPHYLLINE

K854183 is an FDA 510(k) clearance for IN VITRO TEST DETERMINATION OF THEOPHYLLINE, manufactured by Clinical Data, Inc.. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K854183 · Clinical Data, Inc. · Toxicology device
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Dec 1985
Decision
65d
Days
Class 2
Risk

K854183 is an FDA 510(k) clearance for the IN VITRO TEST DETERMINATION OF THEOPHYLLINE. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on December 19, 1985 after a review of 65 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K854183

510(k) Number K854183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date December 19, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
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 K854183.
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
K860464 · Abbott Laboratories · Jun 1986
EMIT CAFFEINE ASSAY
K853872 · Syva Co. · Jun 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
K861367 · Eastman Kodak Company · May 1986
VISION THEOPHYLLINE
K853834 · Abbott Laboratories · Oct 1985
GEMSTAR IPA THEOPHYLLINE TEST KIT
K853372 · Electro-Nucleonics Laboratories, Inc. · Sep 1985
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
K852573 · Technicon Instruments Corp. · Jul 1985