Cleared Traditional

K832825 - SERALYZER THEOPHYLLINE REAGENT STRIPS

K832825 is an FDA 510(k) clearance for SERALYZER THEOPHYLLINE REAGENT STRIPS, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K832825 · Miles Laboratories, Inc. · Toxicology device
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Mar 1984
Decision
213d
Days
Class 2
Risk

K832825 is an FDA 510(k) clearance for the SERALYZER THEOPHYLLINE REAGENT STRIPS. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 213 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K832825

510(k) Number K832825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date March 19, 1984
Days to Decision 213 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
126d slower than avg
Panel avg: 87d · This submission: 213d
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 K832825.
ACCULEVEL THEOPHYLLINE TEST
K844642 · Syva Co. · 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
STRATUS THEOPHYLLINE ASSAY
K832965 · American Dade · Dec 1983
CHEM KIT THEOPHYLLINE DIAG. KIT
K833683 · Abbott Laboratories · Dec 1983
THEOPHYLLINE TEST PACK ACA
K831934 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983