Cleared Traditional

K872142 - INNOFLUOR PHENYTOIN CALIBRATOR SET

K872142 is the FDA 510(k) clearance for INNOFLUOR PHENYTOIN CALIBRATOR SET by Innotron of Oregon, Inc.. It is a Class 2 Chemistry device (product code DLJ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K872142 · Innotron of Oregon, Inc. · Chemistry device
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Jul 1987
Decision
48d
Days
Class 2
Risk

K872142 is an FDA 510(k) clearance for the INNOFLUOR PHENYTOIN CALIBRATOR SET. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - the FDA in vitro diagnostics and chemistry 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 Innotron of Oregon, Inc. devices

Submission Details

510(k) Number K872142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1987
Decision Date July 21, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 94
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K872142.
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · Em Diagnostic Systems, Inc. · Oct 1987
ETHANOL CALIBRATOR
K872181 · American Monitor Corp. · Jul 1987
DIGOXIN FPIA CALIBRATORS
K872328 · Sigma Chemical Co. · Jul 1987
PHENYTOIN FPIA CALIBRATORS
K871423 · Sigma Diagnostics, Inc. · Jun 1987