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.

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 is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Ov

Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy

Device Description

Not Found

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets those criteria. The document is primarily a 510(k) clearance letter from the FDA for a device named "Transferrin, Specical Calibrator, Specitrol Control and Specitrol High Control."

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not include:

A table of acceptance criteria and reported device performance.
Information on sample sizes used for test sets, data provenance (country, retrospective/prospective).
Details about the number or qualifications of experts used to establish ground truth.
Adjudication methods.
Results from a multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of AI assistance.
Results from a standalone algorithm-only performance study.
The type of ground truth used (e.g., pathology, outcomes data).
The sample size for the training set or how its ground truth was established.

The document states the intended use of the devices, which is for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical Chemistry Analyzers, aiding in the diagnosis of malnutrition, acute inflammation, acute infection, and iron deficiency anemia. It also specifies the use of SpeciCal as a stock calibrator and SpeciTrol/SpeciTrol High as assayed control serums to monitor precision.

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, or AI-related metrics based on the provided text.

Summary

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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

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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 (240) 276-0450. 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 (800) 638-2041 or (240) 276-3150 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

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Indications for Use

510(k) Number (if known): K063086

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

Transferrin

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

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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_

Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).