Cleared Traditional

K844642 - ACCULEVEL THEOPHYLLINE TEST

K844642 is an FDA 510(k) clearance for ACCULEVEL THEOPHYLLINE TEST, manufactured by Syva Co.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K844642

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
6d slower than avg
Panel avg: 105d · This submission: 111d
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 Immunology 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 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