ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

K060027 · Biokit, S.A. · JJX · Jan 26, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060027
• Device Name: ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
• Applicant: Biokit, S.A.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma. ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma. For in vitro diagnostic use.

Device Story

ARCHITECT DHEA-S Calibrators and Controls are liquid, human serum-based reagents containing synthetic DHEA-S and sodium azide preservative. Calibrators provide reference points (0, 5, 12, 60, 300, 1500 µg/dL) for the ARCHITECT i System; controls provide verification of accuracy and precision at target levels (10, 100, 1000 µg/dL). Used in clinical laboratory settings by trained personnel to support DHEA-S assay performance. The system utilizes Chemiluminescent Microparticle Immunoassay (CMIA) technology. Output is used by clinicians to monitor DHEA-S levels, aiding in the assessment of adrenal function.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed 6-month shelf life at 2-8°C. Gravimetric preparation and RLU variation testing (acceptance criteria +/- 1.5%) were performed to verify calibrator and control values.

Technological Characteristics

Human serum-based matrix; synthetic DHEA-S analyte; sodium azide preservative. Calibrators: 6 levels (0-1500 µg/dL). Controls: 3 levels (10-1000 µg/dL). Designed for ARCHITECT i2000/i2000sr instrument platforms. Chemiluminescent Microparticle Immunoassay (CMIA) principle. Storage: 2-8°C.

Indications for Use

Indicated for use as calibrators and controls for the quantitative determination of DHEA-S in human serum and plasma on the ARCHITECT i System. For prescription use only.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• DPC IMMULITE® DHEA-SO4 Calibrators and Controls (K935806)

Submission Summary (Full Text)

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K060027

# ARCHITECT ® DHEA-S 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordancewith the requirements of CFR

Preparation date: December 23 rd, 2005

#### Submitter Contact information:

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

#### Device Name:

Calibrators Classification Name: Calibrator, Secondary Trade Name: ARCHITECT ® DHEA -S Calibrators (A-F) Common name: Calibrator Device Classification: 21 CFR 862.1150 Device Class: Class II Classification Panel: Clinical Chemistry Product Code: JIT

#### Controls

Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: ARCHITECT ® DHEA -S Controls (Low, Medium, and High) Common name: Control Device Classification: 21 CFR 862.1660 Device Class: Class I Classification Panel: Clinical Chemistry Product Code: JJX

# Legally marketed device to which equivalency is claimed:

DPC IMMULITE ® DHEA -SO4

### Description of the Device:

#### Calibrators

The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.

### Controls

The ARCHITECT ® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA -S in human serum and plasma.

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Comparison of Technological Characteristics:

# Calibrators
Similarities

| Similarities: | | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Calibrator | Device | Predicate |
| Intended Use | The ARCHITECT® DHEA-S<br>Calibrators are for the calibration<br>of the ARCHITECT i System<br>when used for the quantitative<br>determination of DHEA-S in<br>human serum and plasma. | DHEA-SO4 For the<br>quantatitive determination of<br>dehydroepiandrosterone<br>sulfate in serum. |
| System Methodology | Chemiluminescent Microparticle<br>Immunoassay (CMIA) | Chemiluminescent a solid<br>phase enzyme immunoassay |
| Assay Protocols | Competitive assay | Competitive assay |
| Matrix | DHEA-S (synthetic) in human<br>serum with preservative.<br>(SodiumAzide) | Lyophilized DHEA-SO4 in<br>human serum with<br>preservative |

# Controls

Similarities:

| Controls | Device | Predicate |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ARCHITECT DHEA-S<br>Controls are for the<br>verification of the accuracy and<br>precision of the ARCHITECT <i>i</i><br>System when used for the<br>quantitative determination of<br>DHEA-S in human serum and<br>plasma | For the quantitative<br>determination of<br>dehydroepiandrosterone sulfate<br>in serum intended strictly for in<br>vitro diagnostic use. |
| Methodology | Chemiluminescent<br>Microparticle Immunoassay<br>(CMIA) | Chemiluminescence a solid<br>phase enzyme immunoassay |
| Assay Protocol | Competitive assay | Competitive assay |
| Matrix | DHEA-S (synthetic) in human<br>serum with preservative.<br>(SodiumAzide) | Lyophilized DHEA-SO4 in<br>human serum with preservative |

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#### Calibrators

| Differences: | | |
|--------------------------|---------------------------------------------------------------------------------|------------------------|
| Calibrators | Device | Predicate |
| Platform | ARCHITECT i System | Immulite 2000 Analyzer |
| Traceability | Sigma | Not in package insert |
| Standardization | Value assigned based on mass basis<br>from a DHEA-S preparation (100%<br>pure). | Not in package insert |
| Calibration Range/Levels | 0, 5, 12, 60, 300, and 1500 µg/dL | 15-1,000 µg/dL |

#### Controls 1.66

| Differences | | |
|-------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control | Device | Predicate |
| Platform | ARCHITECT i System | Immulite 2000 Analyzer |
| Matrix | Single constituent, DHEA-S (synthetic)<br>in human serum with preservative.<br>(Sodium Azide) | Multi constituent, Human<br>serum based tri-level control<br>containing over 25<br>constituents commonly<br>measured by immunoassay. |
| Traceability | Sigma | Not in package insert |
| Value Assignment | Relative Light Units matched to<br>secondary controls | Values derived from<br>extensive analysis performed<br>by DPC, and reflect<br>instrument, reagent, and other<br>within laboratory sources of<br>variation. |
| Levels | 10, 100, and 1000 µg/dL | Three levels,<br>2SD range<br>70-102,<br>222-288,<br>481-725 µg/dL<br>[Example lot 020] |
| Assay Sample Type | Serum and plasma | Serum |

#### Conclusion:

As summarized above the ARCHITECT® DHEA-S Calibrators (A-F) and Controls (Low, Medium, and High) are substantially equivalent to the DPC IMMULITE® DHEA-SO4 Colibrators and Controls. Substantial equivalence for the calibrators has been demonstrated as recommended by the FDA guidance for Industry "Abbreviated 510(k) Submission for In Vitro Calibroom" (Issued on: Feb 22, 1999) and for controls as recommended by the FDA Guidance for Industry "Points to Consider Document on Assayed and Unassayed Quality Control Material" (Draft Guidance released for comment on Febuary 3, 1999).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned in the center of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 6 2006

Joan Guixer Director, Quality Assurance and Regulatory Affairs BioKit S.A. Llissa D`Amunt Barcelona, Spain 08186

Re: k060027

> Trade/Device Name: ARCHITECT® DHEA-S CALIBRATORS (A-F) and ARCHITECT® DHEA-S CONTROLS (LOW, MEDIUM, HIGH) Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class II Product Code: JJX, JIT Dated: December 27, 2005 Received: January 4, 2006

Dear Ms. 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).

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

Sincerely yours,

Alberto G

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 Statement

# 510(k) Number (if known): K060027

Device Name: ARCHITECT® DHEA-S CALIBRATORS (A-F) and ARCHITECT ® DHEA-S CONTROLS (LOW, MEDIUM, HIGH)

# Indications for Use:

#### Calibrators

The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.

# Controls

ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.

For in vitro diagnostic use.

Prescription Use × OR (Part 21 CFR 801 Subpart D)

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)

Ann Chappele
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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