Cleared Abbreviated

K121759 - CONE-TROL LIQUID CHEMISTRY CONTROLS

K121759 is an FDA 510(k) clearance for CONE-TROL LIQUID CHEMISTRY CONTROLS, manufactured by Cone Bioproducts. The device is a Class 1 Chemistry device with product code JJY cleared through the Abbreviated 510(k) pathway after a 39-day FDA review.

K121759 · Cone Bioproducts · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
39d
Days
Class 1
Risk

K121759 is an FDA 510(k) clearance for the CONE-TROL LIQUID CHEMISTRY CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Cone Bioproducts (Seguin, US). The FDA issued a Cleared decision on July 24, 2012 after a review of 39 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cone Bioproducts devices

FDA 510(k) Submission Details - K121759

510(k) Number K121759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2012
Decision Date July 24, 2012
Days to Decision 39 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

JJY Device Classification - Class 1, General Controls

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 560
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K121759.
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
K122838 · Bio-Rad Laboratories · Oct 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720 · Randox Laboratories, Ltd. · Sep 2012
THERMO SCIENTIFIC MAS OMNI-CARDIO
K122291 · Microgenics Corporation · Aug 2012
AUDIT MICROLQ SPINAL FLUID CONTROL
K112742 · Aalto Scientific, Ltd. · Jun 2012
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
K111964 · Aalto Scientific, Ltd. · Mar 2012
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
K112705 · Aalto Scientific, Ltd. · Jan 2012