ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

K112443 · Axis-Shield Diagnostics, Ltd. · CDD · Dec 19, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112443
• Device Name: ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
• Applicant: Axis-Shield Diagnostics, Ltd.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Dec 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMA) for the quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. The ARCHITECT Active-B12 (Holotranscobalamin) Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of Holotranscobalamin in human serum. The ARCHITECT Active-B12 (Holotranscobalamin) Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument) when used for the quantitative determination of Holotranscobalamin in human serum.

Device Story

ARCHITECT Active-B12 is a two-step chemiluminescent microparticle immunoassay (CMIA) for quantitative Holotranscobalamin (HoloTC) measurement in human serum. Performed on ARCHITECT i System; sample combined with anti-HoloTC coated paramagnetic microparticles; HoloTC binds to particles; after washing, anti-transcobalamin acridinium-labeled conjugate added; chemiluminescent reaction measured as relative light units (RLUs). RLU signal directly proportional to HoloTC concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing vitamin B12 deficiency.

Clinical Evidence

Method comparison study performed on 125 human serum samples. Correlation coefficient (r) of 0.94 (95% CI: 0.92, 0.96) observed across a range of 8.13 to 124.43 pmol/L HoloTC. Performance deemed substantially equivalent to predicate.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA); uses paramagnetic microparticles and acridinium-labeled conjugate; automated system (ARCHITECT i System); quantitative measurement via RLU detection.

Indications for Use

Indicated for the quantitative determination of holotranscobalamin in human serum as an aid in the diagnosis and treatment of vitamin B12 deficiency. Contraindicated for use with hemolyzed samples; caution advised for patients with potential HAMA or heterophilic antibody interference.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• AxSYM Active-B12 (Holotranscobalamin) (k062467)

Submission Summary (Full Text)

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112443

DEC 1 9 2011

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Submission correspondent:

Dr Claire Dora Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA. Scotland, UK

Device Name: ARCHITECT Active-B12 (Holotranscobalamin) Reagents, ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (A-F) and ARCHITECT Active-B12 (Holotranscobalamin) Controls (Low and High).

## Reagents:

Classification Name: Vitamin B12 test system Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Common Name: Holotranscobalamin test Governing Regulation: 862.1810 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CDD

## Calibrators:

Classification Name: Calibrator Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT

## Controls:

Classification Name: Quality control material (assayed and unassayed) Architect Active-B12 (Holotranscobalamin) 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v2.0 2011-10-10

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Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Control Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX

# Legally marketed device to which equivalency is claimed:

AxSYM Active-B12 (HoloTC) Immunoassay (k062467)

## Intended Use of Device:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) the for quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency:

## Description of Device:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quantitative determination of Holotranscobalamin in human serum using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

In the first step, sample and anti-holotranscobalamin coated paramagnetic microparticles are combined. Holotranscobalamin present in the sample binds to the antiholotranscobalamin coated microparticles. After washing, anti-transcobalamin acridinium-labeled conjugate is added-to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of Holotranscobalamin in the sample and the RLUs detected by the ARCHITECT i System optics.

Architect Active-B12 (Holotranscobalamin) 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v2.0 2011-10-10

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## Comparison of Technological Characteristics:

ARCHITECT Active-B12 (Holotranscobalamin) and AxSYM Active-B12 (HoloTC) are both automated immunoassays for the quantitative determination of Holotranscobalamin (HoloTC).

The ARCHITECT and AxSYM systems differ in their detection methods; the ARCHITECT is a chemiluminescent microparticle immunoassay (CMIA) whereas the AxSYM is a microparticle enzyme immunoassay (MEIA).

## Summary of Non-Clinical Performance:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is substantially equivalent to the AxSYM Active-B12 (HoloTC) assay in terms of precision, calibration, linearity on dilution and specificity as demonstrated in non-clinical performance data in this 510(k) submission.

#### Summary of Clinical Performance:

The ARCHITECT Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent performance to the AxSYM Active-B12 (HoloTC) assay as indicated by a method comparison study.

The ARCHITECT Active-B12 (Holotranscobalamin) assay demonstrated substantially equivalent performance to the AxSYM Active-B12 (HoloTC) as indicated by a method comparison with a correlation coefficient (r) of 0.94 (95% confidence interval 0.92, 0.96) for the 125 samples tested and covering the range of 8.13 to 124.43 pmol/L Holotranscobalamin.

Architect Active-B12 {Holotranscobalamin} 510(k) Premarket notification submission ADMIN 3.0 510(k) Summary Final v2.0 2011-10-10

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of curved lines. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Axis-Shield Diagnostics Ltd c/o Dr. Simon Richards The Technology Park Luna Place Dundee, DD2 1XA,UK

DEC 1 9 2011

Re: k112443

> Trade Name: ARCHITECT Active-B12 (Holotranscobalamin) Reagents, ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (A-F), ARCHITECT Active-B12 (Holotranscobalamin) Controls (A-F),
> Requlation Number: 21/2 (Holotranscobalamin) Controls (Low and High) Regulation Number: 21 CFR §862.1810 Regulation Name: Vitamin B12 test system. Regulatory Class: Class II Product Codes: CDD, JIT, JJX Dated: November 25, 2011 Received: November 29, 2011

Dear Dr. Richards:

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 her lection in the end the marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices marke 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, EDA movemblic be st In addition, FDA may public and art, Coast of Federal Negulations (CFR), Parts 800 to 895.
Register 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 Fequirement 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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## Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely vours.

signature

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): k112443

## Device Name:

Active-B12 (Holotranscobalamin) Reagents, ARCHITECT Active-B12 ARCHITECT (Holotranscobalamin) Calibrators (A-F) and ARCHITECT Active-B12 (Holotranscobalamin) Controls (Low and High)

## Indication For Use:

## Reagents:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMA) for the quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

## Calibrators:

The ARCHITECT Active-B12 (Holotranscobalamin) Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of Holotranscobalamin in human serum.

## Controls:

The ARCHITECT Active-B12 (Holotranscobalamin) Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument) when used for the quantitative determination of Holotranscobalamin in human serum.

Prescription Use x (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112443