ARCHITECT B12 CALIBRATORS

K053330 · Abbott Laboratories · JIT · Dec 16, 2005 · Clinical Chemistry

Device Facts

• Record ID: K053330
• Device Name: ARCHITECT B12 CALIBRATORS
• Applicant: Abbott Laboratories
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Abbott ARCHITECT B12 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma.

Device Story

Abbott ARCHITECT B12 Calibrators; used in clinical laboratory settings by trained personnel. Modification involves increasing calibrator materials from two to six levels (A-F). Calibrator A: borate buffer; Calibrators B-F: cyanocobalamine in borate buffer at 100, 250, 500, 1000, and 2000 pg/mL. Used to establish calibration curves for quantitative Vitamin B12 assays on ARCHITECT immunoassay systems. Output enables accurate quantification of patient Vitamin B12 levels, supporting clinical diagnosis and monitoring of B12 deficiency or related metabolic conditions.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures; results met predetermined acceptance criteria. No clinical data provided.

Technological Characteristics

Liquid, ready-to-use buffered aqueous solution. Calibrator concentrations span the dynamic range of the ARCHITECT i System vitamin B12 assay. No specific materials or software algorithms described beyond standard clinical chemistry calibrator formulation.

Indications for Use

Indicated for use as calibrators for the Abbott ARCHITECT B12 assay to establish the calibration curve for the quantitative determination of Vitamin B12 in human serum or plasma.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Abbott ARCHITECT® B12 (K984108)

Submission Summary (Full Text)

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K 053330

## Special 510(k) Summary Abbott ARCHITECT® B12 Calibrators

## Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

According to the requirements of 21 CFR §807.92, the following information provides of According to the requirements of DF OFF 30 for a determination of substantial equivalence.

| Submitter's Name and Address: | Abbott Laboratories<br>Diagnostics Division<br>100 Abbott Park Road<br>Abbott Park, IL 60064<br>Telephone: [phone]<br>Fax: [phone]<br>Contact: [e-mail] |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Date Prepared: 29 November 2005

| Device Proprietary Name:<br>Device Common Name:<br>Classification Number: | Abbott ARCHITECT® B12 Calibrators<br>Vitamin B12<br>Clinical Chemistry, 21 CFR §862.1150 |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | Abbott ARCHITECT® B12<br>510(k) Number: K984108<br>Concurrence Date: 3 February 1999 |
| Device Description: | The Abbott ARCHITECT B12 Calibrators are<br>liquid, ready-for-use materials in a buffered<br>aqueous solution. Concentrations of the calibrator<br>components span the dynamic range of the assay. |
| Intended Use: | The Abbott ARCHITECT B12 Calibrators are for<br>the calibration of the ARCHITECT i System when<br>used for the quantitative determination of vitamin<br>B12 in human serum and plasma. |

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A correlation analysis was performed between the ARCHITECT B12 6-Point Calibrators and the ARCHITECT 2-Point Calibrators. In this evaluation, serum specimens tested and the ARCHITECT 2-1 only Callorations in The ARCHITECT B12 6-point calibration assay, and from 77 to 1988 pg/mL by the ARCHITECT B12 2-point calibration assay. The evaluation yielded the following results:

| Regression Method | N | r | Slope | Intercept |
|-------------------|-----|-------|-------|-----------|
| Least Squares | 495 | 0.998 | 0.96 | 22 |
| Passing-Bablok | 495 | 0.998 | 0.98 | 12 |

n = number of specimens

r = correlation coefficient

In conclusion, these data demonstrate that the performance of the Abbott ARCHITECT In conclusion, intese uata demonstrate and comparable to the performance of the predicate device, when used according to its intended use.

Prepared and Submitted 29 November 2005 by:

Margaret Bochniak 11/29/05

Margaret Prochniak, M.S. Senior Regulatory Affairs Specialist ADD Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: Margaret [e-mail]

Abbott Laboratories Diagnostics Division Department 9VA, Building AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-6095

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing the feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 16 2005

Ms. Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist Abbott Laboratories Diagnostics Division Dept. 9VA, Bldg. AP 6C-2 100 Abbott Park Road Abbott Park, IL 60064-6095

Re: k053330

Trade/Device Name: Abbott ARCHITECT® B12 Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 29, 2005 Received: December 1, 2005

Dear Ms. Prochniak:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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" (21CFR Part 807.97). 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 yours,

Alberto Guti

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology 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): K 053330

Device Name: Abbott ARCHITECT® B12 Calibrators

Indications For Use:

The Abbott ARCHITECT B12 Calibrators are for the calibration of the The Abbott ARCHITECT BT2 Canbrators are for the canoration of vitamin B12 in human serum and plasma.

Prescription Use _ X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 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)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053330