TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

K063086 · Thermo Electron OY · DDG · Aug 8, 2007 · Immunology

Device Facts

• Record ID: K063086
• Device Name: TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
• Applicant: Thermo Electron OY
• Product Code: DDG · Immunology
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia.

Device Story

Transferrin test system utilizes immunoturbidimetric assay on T60 Clinical Chemistry Analyzers; measures transferrin levels in serum or plasma samples. System includes SpeciCal (stock calibrator for quantification and antigen excess detection) and SpeciTrol/SpeciTrol High (assayed control sera for monitoring test precision). Used in clinical laboratory settings by trained personnel. Output provides quantitative transferrin concentration; aids clinicians in diagnosing malnutrition, acute inflammation, acute infection, and iron deficiency anemia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay; PEG-enhanced immunoprecipitation. Reagents: anti-human transferrin (swine), phosphate-buffered saline, polymers. Analyzed at 340nm. Calibrators standardized against CRM 470 (IFCC/BCR/CAP). Instrument: T60 Clinical Chemistry Analyzer. Storage: 2-8°C. Shelf life: 15 months.

Indications for Use

Indicated for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma to aid in the diagnosis of malnutrition, acute inflammation, acute infection, and iron deficiency anemia. Intended for use on T60 Clinical Chemistry Analyzers.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)", which is arranged in a circular fashion around the top and left side of the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 8 2007

Thermo Electron Scientific OY c/o Päivi Sormunen Vice President of Reagent Business Development and QRC Clinical Diagnostics Finland Ratastie 2, P.O. Box 100 FI-01621 Vantaa Finland

Re: k063086

Trade/Device Name: Transferrin, Specical Calibrator, Specitrol Control and Specitrol High Control Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin immunological test system Regulatory Class: Class II Product Code: DDG, JJY, JIX Dated: June 27, 2007 Received: July 02, 2007

Dear Päive Sormunen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{1}------------------------------------------------

Page 2 -

forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Robert L. Beckerf

Robert L. Becker, Jr., M.D., PH. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known): k063086

- Device Name: Transferrin Specical calibrator Specitrol control Specitrol High control
Indications For Use:

Transferrin

The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Maria McRae
Division Sign-Off

Page 1 of 2

Office of In Vitro Diagnostic Device Evaluation and Safety

51000 K063086

{3}------------------------------------------------

## SpeciCal

For in vitro diagnostic use on T60 analyzer. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy

## SpeciTrol

For in vitro diagnostic use on T60 analyzer. SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Ov

## Specitrol High

For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy

Page 2 of 2_