Cleared Traditional

K911177 - ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II

K911177 is an FDA 510(k) clearance for ACS THERAPEUTIC DRUG MONITORING CONTROL, manufactured by Analytical Control Systems, Inc.. The device is a Class 1 Toxicology device with product code JJX cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K911177 · Analytical Control Systems, Inc. · Toxicology device
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May 1991
Decision
44d
Days
Class 1
Risk

K911177 is an FDA 510(k) clearance for the ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), 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 44 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - 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

FDA 510(k) Submission Details - K911177

510(k) Number K911177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date May 01, 1991
Days to Decision 44 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
43d faster than avg
Panel avg: 87d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 445
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K911177.
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
K912439 · Hybritech, Inc. · Aug 1991
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
K911664 · Quidel Corp. · May 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
K911176 · Analytical Control Systems, Inc. · May 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
K911178 · Analytical Control Systems, Inc. · May 1991
BIOTROL BILIRUBIN C & T CONTROL
K905280 · Biotrol, USA, Inc. · Feb 1991
SERACON CR REFERENCE
K904503 · Bhp Diagnostix, Inc. · Nov 1990