Cleared Traditional

THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II (K911170) - FDA 510(k) Clearance

Class I Toxicology device.

K911170 · Analytical Control Systems, Inc. · Toxicology device
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May 1991
Decision
47d
Days
Class 1
Risk

K911170 is an FDA 510(k) clearance for the THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on May 1, 1991 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1410 - 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 Analytical Control Systems, Inc. devices

Submission Details

510(k) Number K911170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date May 01, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 87d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIY Photometric Method, Iron (non-heme)

All 66
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