Cleared Traditional

K813580 - Q-LINE LTC

K813580 is the FDA 510(k) clearance for Q-LINE LTC by Miles Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K813580 · Miles Laboratories, Inc. · Chemistry device
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Jan 1982
Decision
25d
Days
Class 1
Risk

K813580 is an FDA 510(k) clearance for the Q-LINE LTC. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K813580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1981
Decision Date January 18, 1982
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K813580.
CHEMISTRY CONTROL/STANDARD
K821382 · Medical Analysis Systems, Inc. · May 1982
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242 · Beckman Instruments, Inc. · May 1982
BI-LEVEL ASSAYED URINE METAL CONTROL
K820255 · Ortho Diagnostic Systems, Inc. · Feb 1982
ORTHO CO2 DILUENT LEVEL I
K813293 · Ortho Diagnostic Systems, Inc. · Dec 1981
ORTHO CO2 DILUENT LEVEL II
K813294 · Ortho Diagnostic Systems, Inc. · Dec 1981
ORTHO CO2 DILUENT LEVEL III
K813295 · Ortho Diagnostic Systems, Inc. · Dec 1981