Cleared Traditional

K871394 - THEOPHYLLINE FPIA CALIBRATORS

K871394 is an FDA 510(k) clearance for THEOPHYLLINE FPIA CALIBRATORS, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K871394 · Sigma Diagnostics, Inc. · Toxicology device
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Jun 1987
Decision
55d
Days
Class 2
Risk

K871394 is an FDA 510(k) clearance for the THEOPHYLLINE FPIA CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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

FDA 510(k) Submission Details - K871394

510(k) Number K871394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date June 01, 1987
Days to Decision 55 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
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLJ Device Classification - Class 2, Special Controls

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K871394.
INNOFLUOR VANCOMYCIN CALIBRATOR SET
K872644 · Innotron of Oregon, Inc. · Jul 1987
DIGOXIN FPIA CALIBRATORS
K872328 · Sigma Chemical Co. · Jul 1987
PHENYTOIN FPIA CALIBRATORS
K871423 · Sigma Diagnostics, Inc. · Jun 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330 · Em Diagnostic Systems, Inc. · Apr 1987
DIGOXIN (FPIA) CALIBRATOR KIT
K870389 · Windsor Laboratories, Inc. · Apr 1987
PHENOBARBITAL (FPIA) CALIBRATOR KIT
K870390 · Windsor Laboratories, Inc. · Apr 1987