Cleared Traditional

ANALYST THEOPHYLLINE CALIBRATOR (K884170) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884170 · The DU Pont Co. · Toxicology device
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Nov 1988
Decision
56d
Days
Class 2
Risk

K884170 is an FDA 510(k) clearance for the ANALYST THEOPHYLLINE CALIBRATOR. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by The DU Pont Co. (Wilmington, US). The FDA issued a Cleared decision on November 16, 1988 after a review of 56 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 The DU Pont Co. devices

Submission Details

510(k) Number K884170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1988
Decision Date November 16, 1988
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K884170.
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
K890451 · Syva Co. · Feb 1989
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR
K890452 · Syva Co. · Feb 1989
DU PONT ACA METHOTREXATE CALIBRATOR
K884745 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1989
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A
K883920 · Syva Co. · Oct 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · Em Diagnostic Systems, Inc. · May 1988
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL
K875135 · Syva Co. · Apr 1988