ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

K082141 · Biokit, S.A. · JIT · Sep 3, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082141
• Device Name: ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
• Applicant: Biokit, S.A.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Sep 3, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine. The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

Device Story

ARCHITECT C-Peptide Calibrators and Controls are liquid reagents used with the ARCHITECT i System to calibrate assays and monitor test precision/accuracy. Calibrators consist of synthetic human C-peptide in PBS buffer with horse serum and stabilizers; concentrations range from 0.00 to 30.00 ng/mL. Controls consist of synthetic human C-peptide in PBS buffer with horse serum and stabilizers; concentrations are 1, 4, and 16 ng/mL. Used in clinical laboratory settings by trained personnel. Calibrators establish the system's calibration curve; controls verify system performance and detect analytical deviations. Results assist clinicians in assessing C-peptide levels, which are relevant for evaluating pancreatic beta-cell function.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (freeze-thaw, open vial, transport simulation) confirmed 6-month stability at 2-8°C. Traceability established to WHO standard NIBSC 84/510 via gravimetric dilution and RLU comparison on the ARCHITECT i System.

Technological Characteristics

Materials: PBS buffer, heat-inactivated horse serum, synthetic human C-peptide, ProClin 300/950 preservatives. Principle: Chemiluminescent Microparticle Immunoassay (CMIA). Form factor: Liquid reagents in bottles. Connectivity: Designed for use on the ARCHITECT i System. Sterilization: Not specified.

Indications for Use

Indicated for use as calibrators and controls for the quantitative determination of C-peptide in human serum, plasma, and urine on the ARCHITECT i System.

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

• ADVIA Centaur and ACS:180 C-peptide Calibrator (k021532)
• BAYER Ligand Plus 1,2,3 Controls (k030452)

Submission Summary (Full Text)

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

## SEP - 3 2008

# ARCHITECT C-Peptide

### 510(k) Summary (Summary of Safety and Effectiveness)

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

KOQ214 The assigned 510(k) number is:

Preparation Date:

#### Applicant Name:

Mr. Joan Guixer Director of Quality Assurance and Regulatory Affairs Biokit S.A. Lliça d'Amunt Barcelona, Spain 08186

#### Device Name:

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

#### Controls:

Trade Name: ARCHITECT C-Peptide Controls (Low, Medium and High) Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Chemistry Product Code: JJX

#### Legally marketed device to which equivalency is claimed:

Calibrators: ADVIA Centaur and ACS:180 C-peptide Calibrator (K021532) Controls: BAYER Ligand Plus 1,2,3 Controls (K030452)

#### Intended Use of Device:

The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine,

The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 8 2008

BioKit S.A. Can Male S/N c/o Mr. Joan Guixer Quality Assurance and Regulatory Affairs Director Llica D'Amunt Barcelona, Spain 08186

Re: k082141

> Trade Name: Architect C-Peptide Calibrators, and Architest C-Peptide Controls Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT, JJX Dated: July 28, 2008 Received: July 30, 2008

Dear Mr. Guixer:

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).

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

#### Page 2 -

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

## Indication for Use

510(k) Number (if known):

Device Name: ARCHITECT C-Peptide Calibrators (A -- F) and ARCHITECT C-Peptide Controls (Low, Medium, and High).

Indication For Use:

## Calibrators

The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

## Controls

The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

For in vitro diagnostic use.

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 Affice of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

CA

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

510(k) k082141