Cleared Traditional

K060570 - HEMOGLOBIN ALC CONTROL

K060570 is an FDA 510(k) clearance for HEMOGLOBIN ALC CONTROL, manufactured by Compass Bioscience. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K060570 · Compass Bioscience · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
38d
Days
Class 1
Risk

K060570 is an FDA 510(k) clearance for the HEMOGLOBIN ALC CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Compass Bioscience (Duarte, US). The FDA issued a Cleared decision on April 13, 2006 after a review of 38 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.

FDA 510(k) Submission Details - K060570

510(k) Number K060570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2006
Decision Date April 13, 2006
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 490
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K060570.
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
K062501 · Maine Standards Co. · Sep 2006
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
K060510 · Drew Scientific , Ltd. · Jun 2006
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
K060706 · Liberty Healthcare Group, Inc. · Apr 2006
ALBU TROL, LOW, MODEL 108.001.002
K060215 · Eurotrol B.V. · Mar 2006
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
K060426 · Liberty Healthcare Group, Inc. · Mar 2006
LIBERTY GLUCOSE CONTROL SOLUTION
K060481 · Liberty Healthcare Group, Inc. · Mar 2006
K060570 · HEMOGLOBIN ALC CONTROL
Download PDF FDA Summary Compass Bioscience