510k Information

CAROLINA LIQUID CHEMISTRIES
TECHNICAL BULLETIN
FEBRUARY 2010

This bulletin is meant to provide you with documentation to confirm the 510 clearance of
the Tokyo Boeki Medical System, LTD. In Akiruno, Japan, BioLis 24i.

Carolina Liquid Chemistries, the exclusive, U.S. supplier of Tokyo Boeki Medical
System benchtop chemistry, has been informed that the BioLis 24i has been cleared for
marketing via US FDA 510k number K040958 on February 15, 2005 under the names of
Prestige 24i, Prestige 400, and MGC 240. Tokyo Boeki’s 510k submission annotates
these as the Proprietary and Established names of the analyzer. Further annotation states
that “These are the same models except the names.”

The US FDA Web site link to verify this information is:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=14915

To answer the questions “Why isn’t the Biolis 24i recorded in the US FDA 510k
clearances?” please refer to the US FDA Establishment Registration Device Listing
database for Tokyo Boeki.

Tokyo Boeki lists the following Clinical Chemistry Analyzers on the US FDA
Establishment Registration Device Listing Web page. Please note that these are the same
analyzers under different names as cleared under the 510k number K040958. In
summary, the BioLis 24i is the same instrument as all others listed below, simply another
name.

BIOLIS 24I MGC 240 SIRRUS Biolis 24i
Premium Biolis
24iPremium
Series

Diag Premium LABMAX 240
Premium MGC 240
Premium Prestige 24I Prestige 24i
Premium

SAPPHIRE 400
Premium SIRRUS
Premium SPA Premium TMS-1024i
Premium TRX-7010

The US FDA Web site link to verify this information is:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

You will have to the type in Tokyo Boeki in the Establishment Name box. Please note
that to have a device listing on the US FDA Establishment Registration Device Listing
database the firm must have a cleared 510k number; in this case 510k number K040958.

The Biolis (Prestige 24i) 510k clearance was for Ion Specific Electrolytes (ISE)
Potassium, Chloride, and Sodium. Additional chemistries were submitted to the US FDA
510k Premarket Approval Process by Stanbio Laboratory of Boerne, Texas, US FDA
Registration number 1616487. Stanbio submitted these additional chemistries under the
requirements of Clinical Laboratory Improvement Amendments (CLIA) with Analyte
Specialty and Complexity identifiers as General Chemistry and Moderate respectively.

The US FDA Web site link to verify this information is:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm

You will have to type in Stanbio in the Test System/Manufacture box.

To summarize this information, the conclusion is that the Carolina Liquid Chemistries
Biolis 24i, along with the ISEs and chemistry reagents are cleared by the FDA.



James M. Henneman
Director Regulatory Affairs and Quality Assurance