Cleared Traditional

K844642 - ACCULEVEL THEOPHYLLINE TEST

K844642 is the FDA 510(k) clearance for ACCULEVEL THEOPHYLLINE TEST by Syva Co.. It is a Class 2 Immunology device (product code KLS) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K844642 · Syva Co. · Immunology device
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Mar 1985
Decision
111d
Days
Class 2
Risk

K844642 is an FDA 510(k) clearance for the ACCULEVEL THEOPHYLLINE TEST. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on March 19, 1985 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3880 - the FDA immunology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K844642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1984
Decision Date March 19, 1985
Days to Decision 111 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 104d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Immunology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K844642.
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
K852573 · Technicon Instruments Corp. · Jul 1985
ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
K851741 · Syva Co. · Jun 1985
ICS THEOPHYLLINE REAGENTS
K850856 · Beckman Instruments, Inc. · Mar 1985
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
K844170 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
DUPONT THEOPHYLLINE ASSAY KIT
K841656 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825 · Miles Laboratories, Inc. · Mar 1984