Cleared Traditional

K870952 - THEOPHYLLINE FPIA REAGENT SET

K870952 is the FDA 510(k) clearance for THEOPHYLLINE FPIA REAGENT SET by Sigma Diagnostics, Inc.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K870952 · Sigma Diagnostics, Inc. · Toxicology device
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Mar 1987
Decision
21d
Days
Class 2
Risk

K870952 is an FDA 510(k) clearance for the THEOPHYLLINE FPIA REAGENT SET. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 31, 1987 after a review of 21 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K870952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1987
Decision Date March 31, 1987
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
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 Toxicology 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 K870952.
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257 · Immunotech Corp. · May 1988
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · Syva Co. · Nov 1987
DART THEOPHYLLINE REAGENT SYSTEM
K870736 · Coulter Electronics, Inc. · Apr 1987
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041 · Em Diagnostic Systems, Inc. · Nov 1986
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
K862955 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
K862350 · Em Diagnostic Systems, Inc. · Jul 1986