VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

K063720 · Ortho-Clinical Diagnostics · DHA · Apr 9, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063720
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: DHA · Clinical Chemistry
• Decision Date: Apr 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack For quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy. VITROS Immunodiagnostic Products Total ß-hCG II Calibrators For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.

Device Story

VITROS Immunodiagnostic Products Total β-hCG II assay is an in vitro diagnostic reagent system used on the VITROS Immunodiagnostic System. It measures hCG and its β-subunit in human serum and plasma samples. The system utilizes a chemiluminescent immunometric assay principle; biotin-conjugated monoclonal mouse anti-β-hCG antibodies capture the analyte; horseradish peroxidase serves as the luminescent label. The system automates the immunoassay process, including sample handling and signal detection. Healthcare providers use the quantitative output to aid in the early detection of pregnancy. The device is intended for use in clinical laboratory environments by trained laboratory personnel. The system provides automated results that assist clinicians in confirming pregnancy status.

Clinical Evidence

Bench testing only. Performance data includes analytical sensitivity (0.70 mIU/mL), measuring range (up to 15,000 mIU/mL), and precision (Within-Run CV 1.1-2.5%, Within-lab CV 2.9-4.2%). Specificity testing showed ≤ 10% cross-reactivity for FSH, LH, and TSH. Expected values were established across gestational ranges.

Technological Characteristics

Chemiluminescent immunometric assay. Uses biotin-conjugated monoclonal mouse anti-β-hCG antibodies and horseradish peroxidase label. Solid phase separation via coated microwells. Instrumentation: VITROS Immunodiagnostic System. Sample volume: 40 µL. Connectivity: Integrated with VITROS system. Sterilization: Not applicable (reagents).

Indications for Use

Indicated for quantitative measurement of hCG and its β-subunit in human serum and plasma to aid in early pregnancy detection. For prescription use only.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• Abbott Laboratories, ARCHITECT® SYSTEM Total β-HCG assay (K983424)
• VITROS Immunodiagnostic Products Total β-hCG Range Verifiers (K970894)

Submission Summary (Full Text)

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### 510(k) Summary I

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.

K063720 The assigned 510(k) number is: _

### Submitter Name, Address and Contact 1

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 [phone]

Contact Person: Sarah CV Parsons, RAC

### Preparation Date 2

Date 510(k) prepared: December 14, 2006

### 3 Device Name

VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack VITROS Immunodiagnostic Products Total β-hCG II Calibrators VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers

Common Name: Total ß-hCG II Assay

Classification Name(s): Human chorionic gonadotropin (HCG) test system (21 CFR 862.1155) Calibrators (21 CFR 862.1150) Ouality Control material (assayed and unassayed) (21 CFR 862.1660)

Classifications: The Clinical Chemistry and Toxicology Panel of the FDA has placed the Human chorionic gonadotropin (HCG) test system as a Class II Medical Device. The Microbiology Device Panel has classified Calibrators as Class II Medical Devices (21 CFR 862.1150). The Microbiology Device Panel has classified Controls as Class I Medical Devices (21 CFR 862.1660)

Product Code: DHA, JIT, JJX

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Manufacturing Establishment 9680658 Registration Number:

Ortho Clinical Diagnostics, Inc. Manufacturer Site: Forest Farm Estate Cardiff United Kingdom CF14 7YT

### Predicate Device 4

Ortho-Clinical Diagnostics, Inc. believes that the VITROS Immunodiagnostic Products Total B-hCG II assay and VITROS Immunodiagnostic Products Total BhCG II Range Verifiers are substantially equivalent to the Abbott Laboratories, ARCHITECT® SYSTEM Total ß-HCG assay (K983424) and VITROS Immunodiagnostic Products Total B-hCG Range Verifiers (K970894).

#### 5 Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The assay is comprised of three main elements:

1) The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack, the VITROS Immunodiagnostic Products Total B-hCG II Calibrators, and the VITROS Immunodiagnostic Products Total B-hCG II Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS Total B-hCG II assay).

2) The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).

3) Common reagents - used by the VITROS Immunodiagnostic System in each assay include the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS

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Immunodiagnostic Products Total β-hCG Calibrators 510(k) premarket notification (K970894).

The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

#### Device Intended Use 6

VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack For quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.

VITROS Immunodiagnostic Products Total ß-hCG II Calibrators For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin).

VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.

#### 7 Comparison to Predicate Device

Ortho-Clinical Diagnostics, Inc. believes that the VITROS Immunodiagnostic Products Total B-hCG II assay and VITROS Immunodiagnostic Products Total BhCG II Range Verifiers are substantially equivalent to the Abbott Laboratories, ARCHITECT® SYSTEM Total B-HCG assay (K983424) assay and VITROS Immunodiagnostic Products Total B-hCG Range Verifiers (K973517). Tables 1 through 4 compare the VITROS Immunodiagnostic Products Total 3hCG II assay and Range Verifiers to the Abbott Laboratories, ARCHITECT® SYSTEM Total B-HCG II assay and VITROS Immunodiagnostic Products Total B-hCG Range Verifiers.

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## Table 1 Comparison of the VITROS Immunodiagnostic Products Total βhCG II assay to the Abbott Laboratories, ARCHITECT® SYSTEM Total β-HCG assay: Similarities

| Similarities | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Device<br>Characteristic | New device | Predicate device | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intended<br>Use | For the quantitative measurement of human<br>chorionic gonadotropin (hCG) and its β-subunit in<br>human serum and plasma (EDTA and heparin) | ... for the quantitative and qualitative determination<br>of beta-human chorionic gonadotropin (β-hCG) in<br>human serum and plasma ... | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Basic<br>principle | chemiluminescent immunometric assay | Chemiluminescent Microparticle Immunoassay | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Antibody | conjugated monoclonal mouse anti-β-hCG | Conjugated monoclonal mouse anti-β-hCG | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sample<br>type | Serum and Plasma (EDTA and heparin) | Serum and Plasma (EDTA and heparin) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Expected<br>Values | LMP n Min Max 2.5 97.5 1-10 112 44.71 256,740 63.7 150,854 11-15 43 11,556 265,380 11,795 151,996 16-20 50 7,480.8 111,954 9,383.8 61,410 23-40 45 1,531.1 101,566 1,737.2 98,576 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | LMP n Min Max 2.5 97.5 1-10 50 <1.20 >225,000.00 201.6 >225,000.00 11-1 50 16,995.65 >225,000.00 22,536.49 >225,000.00 16-20 50 8,860.23 >225,000.00 8,006.62 50,238.60 23-40 50 1,583.40 65,911.30 1,599.80 49,412.65 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Measuring<br>Range | Up to 15,000 mIU/mL | Up to 15,000 mIU/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Precision | Within-Run (CV 1.1-2.5%), Within-lab (2.9-4.2%) | Within-Run (CV 1.2-4.7%), Total (CV 1.6-4.9%) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Analytical<br>Sensitivity | 0.70 mIU/mL | ≤ 1.2 mIU/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Specificity | ≤ 10% for FSH, LH and TSH | ≤ 10% for FSH, LH and TSH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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### Comparison of the VITROS Immunodiagnostic Products Total ß-Table 2 hCG II assay to the Abbott Laboratories, ARCHITECT® SYSTEM Total ß-HCG assay: Differences

| Differences | | |
|--------------------------|----------------------------------------------------------|---------------------------------------------------------------|
| Device<br>Characteristic | New device | Predicate device |
| Intended Use | Indication not in statement. | ... for the early detection of pregnancy |
| Sample volume | 40 $ \mu $ L | 75 $ \mu $ L |
| Antibodies | Biotin conjugated mouse<br>monoclonal anti- $\beta$ -hCG | Mouse monoclonal anti- $\beta$ -hCG coated<br>microparticles. |
| Luminescent label | Horse radish peroxidase | acridinium |
| Instrumentation | VITROS Immunodiagnostic<br>System | ARCHITECT SYSTEM |
| Calibrator levels | Three levels | Six levels |

### Comparison of the VITROS Immunodiagnostic Products Total β-Table 3 hCG II Range Verifiers to the VITROS Immunodiagnostic Products Total ß-hCG Range Verifiers: Similarities

| Similarities | | | | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Device<br>Characteristic | New device | Predicate device | | | |
| Intended Use | For in vitro use in verifying the<br>calibration range of the VITROS<br>Immunodiagnostic System when<br>used for the measurement of<br>human chorionic gonadotropin<br>(hCG) and its ß-subunit | For in vitro use in verifying the<br>calibration range of the VITROS<br>Immunodiagnostic System when<br>used for the measurement of human<br>chorionic gonadotropin (hCG) and<br>its ß-subunit | | | |
| Levels | Low and High | Low and High | | | |
| Format | Freeze-dried | Freeze-dried | | | |

### Comparison of the VITROS Immunodiagnostic Products Total β-Table 4 hCG II Range Verifiers to the VITROS Immunodiagnostic Products Total β-hCG Range Verifiers: Differences

| Differences | | |
|--------------------------|---------------------------|-------------------------------|
| Device<br>Characteristic | New device | Predicate device |
| Matrix | Human plasma | Bovine serum |
| Antigen | Bacterial Recombinant hCG | Purified from human urine hCG |

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#### 8 Conclusions

The data presented in the premarket notification provide a reasonable assurance that the VITROS Total B-hCG II Reagent Pack, VITROS Total ß-hCG II Calibrator and VITROS Total ß-hCG II Range Verifiers are safe and effective for the stated intended uses and is substantially equivalent to the cleared predicate devices.

The VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack and the VITROS Immunodiagnostic Products Total β-hCG II Calibrator were compared to the Abbott Laboratories, ARCHITECT® SYSTEM Total β-HCG assay. The VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers were compared to the VITROS Immunodiagnostic Products Total ß-hCG Range Verifiers.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

2098 Gaither Road

Rockville MD 20850

Food and Drug Administration

APR - 9 2007

Ms. Sarah CV Parsons, RAC Ortho-Clinical Diagnostics, Inc. Regulatory Affairs, MC00881 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: k063720

> Trade/Device Name: Vitros Immunodiagnostic Products Total B-HCG II reagent PA Vitros Immunodiagnostic Products Total B-HCG II Calibrators Vitros Immunodiagnostic Products Total B-HCG II Range Verifiers Regulation Number: 21 CFR § 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA, JIT, JJX Dated: March 26, 2007 Received: March 27, 2007

Dear Ms. Parsons:

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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### Indications for Use 1

# Page 1 of 1

K063720

510(k) Number (if known):

Device Name:

VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack VITROS Immunodiagnostic Products Total B-hCG II Calibrators VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers

## Indications for

Use:

For quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.

For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin).

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.

Prescription Use (Part 21 CFR 801 Subpart D) AND/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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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