Cleared Traditional

K010030 - LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR

K010030 is an FDA 510(k) clearance for LIQUISPX HDL/LDL LIQUID CHOLESTEROL CAL..., manufactured by Synergent Biochem Inc.-Clinical Controls Div.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K010030 · Synergent Biochem Inc.-Clinical Controls Div. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
42d
Days
Class 2
Risk

K010030 is an FDA 510(k) clearance for the LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Synergent Biochem Inc.-Clinical Controls Div. (Hawaiian Gardens, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Synergent Biochem Inc.-Clinical Controls Div. devices

FDA 510(k) Submission Details - K010030

510(k) Number K010030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2001
Decision Date February 14, 2001
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 271
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K010030.
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N PROTEIN STANDARD SL
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ELECSYS CORTISOL CALCHECK
K000576 · Roche Diagnostics Corp. · Mar 2000