ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

K063232 · Biokit, S.A. · CEW · Jun 19, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063232
• Device Name: ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
• Applicant: Biokit, S.A.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Jun 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hypercalcemia, hypocalcemia and parathyroid disorders. The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma. The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

Device Story

ARCHITECT Intact PTH assay is a two-step sandwich chemiluminescent microparticle immunoassay (CMIA) performed on the ARCHITECT i System. Input: human serum or plasma sample. Process: sample, assay diluent, and anti-PTH coated paramagnetic microparticles combined; intact PTH binds to microparticles; wash cycle; anti-PTH acridinium-labeled conjugate added; second wash cycle; pre-trigger and trigger solutions added. Output: chemiluminescent signal measured as relative light units (RLUs). System optics detect RLUs, which are directly proportional to intact PTH concentration. Results compared against calibration curve to determine PTH concentration. Used in clinical laboratory settings by trained personnel. Output assists clinicians in differential diagnosis of calcium and parathyroid disorders.

Clinical Evidence

Bench testing only. Performance demonstrated via correlation studies comparing the ARCHITECT Intact PTH assay to the Roche Elecsys PTH predicate. Results showed a correlation coefficient of 0.99 for both routine and STAT protocols.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA) technology. Utilizes anti-PTH coated paramagnetic microparticles and acridinium-labeled conjugate. Detection via chemiluminescent reaction measured as relative light units (RLUs). Designed for use on the ARCHITECT i System. In vitro diagnostic use.

Indications for Use

Indicated for use as an aid in the differential diagnosis of hypercalcemia, hypocalcemia, and parathyroid disorders in patients requiring quantitative determination of intact PTH in human serum and plasma.

Regulatory Classification

Identification

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Predicate Devices

• Roche Elecsys Parathyroid Hormone Test System (k992680)

Submission Summary (Full Text)

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# 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.

k063232 The Assigned 510(k) Number is:

Preparation Date: October 17, 2006

# Applicant Name:

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

### Device Name:

Reagents Classification Name: Parathyroid Hormone test system Trade Name: ARCHITECT® iPTH Immunoassay Common Name: iPTH test Governing Regulation: 862.1545 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CEW

## Calibrators:

Classification Name: Calibrator, Secondary Trade Name: ARCHITECT® iPTH Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT

Controls:

Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: ARCHITECT® iPTH Controls Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX

ARCHITECT iPTH 510k Submission 510k_Summary Final Page 1 of 3

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# Legally marketed device to which equivalency is claimed:

The ROCHE® Elecsys Parathyroid Hormone Test System (K992680) is used as the predicate device.

# Intended Use of Device:

The ARCHITECT® Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.

The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

## Indications for use of the device:

The ARCHITECT Intact PTH assay as an aid in the differential diagnosis of hypercalcemia, hypocalcemia and parathyroid disorders.

# Description of Device:

The ARCHITECT Intact PTH assay is a two-step sandwich immunoassay for the quantitative determination of intact PTH in human serum and plasma using CM1A technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-PTH coated paramagnetic microparticles are combined. Intact PTH present in the sample binds to anti-PTH coated microparticles. After washing, the anti-PTH acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger 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 intact PTH in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of intact PTH in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT Intact PTH calibration.

## Comparison of Technological Characteristics:

The ARCHITECT Intact PTH assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative determination of the intact PTH in human serum or plasma. The ROCHE Elecsys PTH assay uses streptavidin-coated microparticles for the determination of the routine intact PTH in human serum and plasma.

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# Summary of Non-Clinical Performance:

The ARCHITECT Intact PTH assay is substantially equivalent to the Roche Elecsys PTH.

The ARCHITECT Intact PTH demonstrated substantially equivalent performance to the Roche Elecsys PTH for the ROUTINE protocol with a correlation coefficient of 0.99 and for the STAT protocol with a correlation coefficient of 0.99.

# Summary of Clinical Performance:

The ARCHITECT Intact PTH demonstrated substantially equivalent performance to the Roche Elecsys PTH with a correlation coefficient of 0.99.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

BioKit S.A. c/o Mr. Joan Guixer Quality Assurance and Regulatory Affairs Can Male s/n Llica dAmunt Barcelona, Spain 08186

JUN 1 9 2007

Re: k063232

> Trade/Device Name: Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High) Regulation Number: 21 CFR §862.1545 Regulation Name: Parathyroid hormone test system, Regulatory Class: Class II Product Code: CEW, JJX, JIT Dated: May 21, 2007 Received: May 24, 2007

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).

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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 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

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#### ARCHITECT Intact PTH Indications for Use Statement ADMIN 5.0

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

Device Name: ARCHITECT® Intact PTH REAGENTS, CALIBRATORS (A-F) and CONTROLS (LOW, MEDIUM, HIGH)

### Indications for Use: Reagents

The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders.

#### Calibrators

The ARCHITECT Intact PTH Calibrators are for the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.

#### Controls

The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

For in vitro diagnostic use.

Prescription Use × (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)

gnostic Devices (CIVD)
Carol C. Benson
on Sign-Off

ARCHITECT iPTH 510k Submission Indications_for_Use_Statement_Fina!

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Tice of In Vitro Diagnostic Device Coluation and Safety

K063232