Cleared Traditional

K010864 - ANALYST PANELS + ANALYTICAL TEST ROTOR

K010864 is the FDA 510(k) clearance for ANALYST PANELS + ANALYTICAL TEST ROTOR by Hemagen Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K010864 · Hemagen Diagnostics, Inc. · Chemistry device
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May 2001
Decision
60d
Days
Class 2
Risk

K010864 is an FDA 510(k) clearance for the ANALYST PANELS + ANALYTICAL TEST ROTOR. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on May 21, 2001 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K010864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2001
Decision Date May 21, 2001
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K010864.
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
K042362 · Diagnostic Chemicals , Ltd. · Dec 2004
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
K032377 · Roche Diagnostics Corp. · Aug 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · Roche Diagnostics Corp. · Jul 2003
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc. · Mar 2001
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · Diagnostic Chemicals , Ltd. · Sep 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133 · Ortho-Clinical Diagnostics, Inc. · Apr 2000