VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III

K052819 · Ortho-Clinical Diagnostics, Inc. · DEM · Dec 23, 2005 · Immunology

Device Facts

• Record ID: K052819
• Device Name: VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DEM · Immunology
• Decision Date: Dec 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Intended Use

VITROS Chemistry Products AAT Reagent is used to quantitatively measure α1-antitrypsin concentration in human serum. The measurement of α1-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5, 1 FS Chemistry systems for the quantitative measurement of α1-Antitrypsin (AAT). VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5, 1 FS Chemistry systems.

Device Story

VITROS Chemistry Products AAT Reagent is an in vitro diagnostic assay for quantitative measurement of alpha-1 antitrypsin (AAT) in human serum. Used on VITROS 5, 1 FS Chemistry systems; device utilizes immunoturbidimetric methodology. System automatically dilutes samples, calibrators, and controls; mixes with polymer-containing buffer and goat antisera specific to human AAT. Resulting antigen/antibody complexes increase solution turbidity, measured spectrophotometrically at 340nm. Turbidity is proportional to AAT concentration. Calibration curve, generated via five-level calibrator kit, allows determination of unknown sample concentrations. Intended for clinical laboratory use to assist in diagnosing liver cirrhosis and pulmonary emphysema.

Clinical Evidence

Bench testing only. Performance was validated through correlation studies comparing the VITROS AAT assay to the IMMAGE AAT assay using patient samples. Passing & Bablock linear regression analysis yielded y = 0.93x + 2.06 mg/dL. Additional bench testing included evaluation of precision, specificity, expected values, limit of detection, dilution, and specimen matrix effects.

Technological Characteristics

Quantitative immunoturbidimetric assay. Reagents: dual-chambered liquid (buffer with polymer; goat anti-human AAT antisera). Measurement: spectrophotometric at 340nm. Calibration: 5-level liquid calibrator kit (36-360 mg/dL), traceable to ERM-DA 470. Controls: assayed performance verifiers. Platform: VITROS 5, 1 FS Chemistry systems. Sample matrix: serum.

Indications for Use

Indicated for the quantitative measurement of α₁-antitrypsin in human serum to aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Predicate Devices

• IMMAGE® Immunochemistry Systems AAT assay (K964766)
• IMMAGE® Immunochemistry Systems Calibrator 2 (K973932)
• VITROS Chemistry Products Protein Performance Verifiers I, II & III (K042477)

Submission Summary (Full Text)

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DEC 2 3 2005

Image /page/0/Picture/1 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a stylized caduceus symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a sans-serif font. A thin line underlines the text, emphasizing the company name.

Johnion company a Johnson

100 Indigo Creek Drive
Rochester, New York 14626-510!

## 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.

The assigned 510(k) number is: K052819

| 1. Submitter name, address, contact | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive<br>Rochester, New York 14626-5101<br>[phone]<br>Contact Person: Darlene Phillips |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Preparation Date | October 3, 2005 |
| 3. Device name | Trade or Proprietary Names:<br>VITROS Chemistry Products AAT Reagent<br>VITROS Chemistry Products Calibrator Kit 99<br>VITROS Chemistry Products AAT Performance Verifiers I, II & III<br><br>Common Names:<br>Alpha-1-antitrypsin (AAT) assay and controls<br><br>Classification Names:<br>Alpha-1-antitrypsin immunological test system (866.5130) Class II<br>Calibrator (862.1150) Class II<br>Quality Control material (assayed and unassayed) (862.1660) Class I<br>(general controls). Since these devices (AAT Performance Verifiers I, II & III) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act. |

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| 4. Predicate<br>Devices | The VITROS Chemistry Products AAT assay is substantially<br>equivalent to the IMMAGE® Immunochemistry Systems AAT<br>assay. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The VITROS Chemistry Products AAT Performance Verifiers are<br>substantially equivalent to the previously cleared VITROS<br>Chemistry Products Protein Performance Verifiers. |
| 5. Device<br>description | The VITROS Chemistry Products AAT Reagent is used in<br>conjunction with the VITROS Chemistry Products Calibrator Kit 99<br>and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline)<br>on VITROS 5,1 FS Chemistry Systems for the quantitative<br>measurement of α₁-antitrypsin (AAT) in human serum. |
| | The VITROS AAT Reagent is a dual chambered package containing<br>ready-to-use liquid reagents. Samples, calibrators and controls are<br>automatically diluted in saline from VITROS FS Diluent Pack 2 and<br>mixed with Reagent 1 containing a polymer. Addition of antisera<br>specific for human α₁-antitrypsin (Reagent 2) produces an<br>immunochemical reaction yielding antigen/antibody complexes. The<br>light scattering properties of the antigen/antibody complexes<br>increase solution turbidity proportional to α₁-antitrypsin<br>concentration in the sample. The turbidity is measured<br>spectrophotometrically at 340 nm. Once a calibration has been<br>performed for each reagent lot, the a1-antitrypsin concentration in<br>each unknown sample can be determined using the stored calibration<br>curve and the measured absorbance obtained in the assay of the<br>sample. |
| | The VITROS Chemistry Products Calibrator Kit 99 are prepared<br>from processed human serum to which inorganic salts, buffers, and<br>preservatives have been added. These standards are used to<br>calibrate VITROS 5,1 FS Chemistry Systems for the quantitative<br>measurement of α₁-antitrypsin (AAT). |
| | The VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline)<br>is a common reagent that is used by multiple assays on the VITROS<br>5,1 FS System. This is a dual chambered package containing two<br>ready-to-use liquid diluents. Diluent 1 is prepared from processed<br>water to which inorganic salt has been added. Diluent 2 is prepared<br>from processed water to which bovine serum albumin, inorganic<br>salts and preservatives have been added. |
| | The VITROS 5,1 FS Chemistry System is a clinical chemistry<br>instrument that provides automated use of the VITROS Chemistry<br>Products MicroTip® and MicroSlides® range of products. The<br>VITROS 5,1 FS System was cleared for market by 510(k) premarket<br>notification (K031924). |
| 6. Device<br>intended<br>uses | VITROS Chemistry Products AAT Reagent: For in vitro diagnostic<br>use only. VITROS Chemistry Products AAT Reagent is used to<br>quantitatively measure α₁-antitrypsin concentration in human serum. |
| | VITROS Chemistry Products Calibrator Kit 99: For in vitro<br>diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is<br>used to calibrate VITROS 5,1 FS Chemistry Systems for the<br>quantitative measurement of α1-antitrypsin (AAT). |
| | VITROS Chemistry Products AAT Performance Verifiers I, II &<br>III: For in vitro diagnostic use only. VITROS Chemistry Products<br>AAT Performance Verifiers are assayed controls used to monitor<br>performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry<br>Systems. |
| 7. Comparison<br>to<br>predicate<br>devices: | The VITROS Chemistry Products AAT Reagent and VITROS Chemistry<br>Products Calibrator Kit 99 are substantially equivalent to the IMMAGE®<br>Immunochemistry Systems AAT Reagent (K964766) and Calibrator 2<br>(K973932) (predicate devices) which were cleared by the FDA for IVD<br>use.<br>Passing & Bablock linear regression analysis demonstrated the following |
| | relationship:<br>$y = 0.93x + 2.06 mg/dL$<br>where y = results obtained using the VITROS Chemistry Products AAT<br>assay and x = results obtained with the commercially available system<br>IMMAGE® Immunochemistry Systems AAT assay in conventional units. |
| | The VITROS Chemistry Products AAT Performance Verifiers I, II & III<br>are substantially equivalent to the VITROS Chemistry Products Protein<br>Performance Verifiers I, II & III (K042477) (predicate device) which was<br>cleared by the FDA for IVD use. |

The VITROS Chemistry Products AAT Performance Verifiers I, II and III are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These are assayed controls used to monitor performance of VITROS AAT Reagent on VITROS 5,1 FS Chemistry Systems.

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In addition to correlation studies, bench testing was performed to nr addition to corrention station, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS AAT assay.

- Similarities and differences of the assays performed using the VITROS AAT Table 1 assay and the IMMAGE® AAT assay.

| Device Similarities | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Indications for Use | For in vitro diagnostic use. Quantitative measurement of α₁-antitrypsin in human samples. The measurement of α₁-antitrypsin in serum aids in the diagnosis of α₁-antitrypsin deficiency. | |
| Antibody source | Ovine (Goat) | |
| Instrumentation | Clinical chemistry analyzer | |
| Calibrator matrix | Human serum | |
| Differences | | |
| Device Characteristic | VITROS AAT assay<br>(New device) | IMMAGE AAT assay<br>(Predicate device) |
| Sample Type | Serum | Serum |
| Reportable Range | 30.00 - 450.00 mg/dL | 10 - 3,600 mg/dL |
| Calibrator levels | Five levels | Single level |
| Calibrator format | Liquid | Lyophilized |
| Method | Immunoturbidimetric | Nephelometric |

- Similarities and differences of the device characteristics between the VITROS Table 2 AAT Performance Verifiers I, II & III with the predicate device VITROS Chemistry Products Protein Performance Verifiers I, II & III.

| Device Similarities | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications for Use | For in vitro diagnostic use. Assayed controls used to monitor the performance on VITROS Chemistry Systems. | |
| Matrix | The performance verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. | |
| Format | Liquid | |
| Number of levels | Three | |
| Differences | | |
| Device<br>Characteristic | VITROS AAT Performance<br>Verifiers<br>(New Device) | VITROS Protein Performance<br>Verifiers<br>(Predicate Device) |
| Analytes<br>Reported | α₁-Antitrypsin (AAT) | Several including complement C3 (C3), complement C4 (C4), IgA, IgG, IgM and transferrin. |

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- 8. Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products AAT Reagent, VITROS Chemistry Products Calibrator Kit 99, and the VITROS Chemistry Products AAT Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.

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VITROS Chemistry Products AAT assay and controls

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:

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Image /page/6/Picture/0 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.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Ortho-Clinical Diagnostics, Inc. c/o Ms. Darlene J. Phillips Regulatory Affairs Associate 100 Indigo Creek Dr. Rochester, NY 14626-5101

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## DEC 2 3 2005

Re: k052819

Trade/Device Name: VITROS Chemistry Products AAT Reagent VITROS Chemistry Products Calibrator Kit 99 VITROS Chemistry Products AAT Performance Verifiers I, II and III Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1 antitrypsin immunological test system Regulatory Class: Class II Product Code: DEM, JIX, JJX Dated: October 3, 2005 Received: October 25, 2005

Dear Ms. Phillips:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rotty programially equivalent (for the indications for referenced above and nave actemination arketed predicate devices marketed in interstate commerce use stated in the encrosure/ to regally than of the Medical Device Amendments, or to devices that provision in way 26, 1770, the enadinee with the provisions of the Federal Food, Drug, and Cosmetic Ilave bech reclassified in accordance wof a premarket approval application (PMA). You may, Act (Act) that do the require apprect to the general controls provisions of the Act. The general therefore, market the device, salgos to annual registration, listing of devices, good controls provisions of the of the prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc ao or) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. 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 I loase be advised mark i 27 r o sessan that your device complies with other requirements of the Act or that FDA nas made a decemination that yostered by other Federal agencies. You must comply with ally Federal statutes and regaration abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, moractice requirements as set forth in the quality fabeling (21 CFR Part 800); and if applicable, the electronic product radiation systems (QB) 10gars (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mailing of substantial equivalence of your device to legally

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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs and the may on any and 2011 - Alama descreeness the requirely of If you desire specific advice for your dones at [phone]. Also, please note the regulation of contact the Uffice of Compliance at (240) 210 other Pat 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obta "Misbranding by reference to premailsoriise under the Act from the Division of Small
general information on your responsibilities under the Act from the (800) 6 general information on your responsibilities and reveal and the toll-free number [phone] or [phone] or at its Internet address

[phone] of arts microstaaaaaaaaa.html

Sincerely yours,

Robert L. Becker, Jr., M.D., PhD

Director Division of Immunology and Hematology Devices Division of Initialisms.
Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

______________________________________________________________________________________________________________________________________________________________________________

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Page 1 of 1

| 510(k) Number (if known): | K052819 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products AAT Reagent<br>VITROS Chemistry Products Calibrator Kit 99<br>VITROS Chemistry Products AAT Performance Verifiers I, II, and III |
| Indications for Use: | For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products AAT Reagent is used to quantitatively measure α₁-antitrypsin concentration in human serum. The measurement of α₁-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.<br><br>For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).<br><br>For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry Systems. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
| | AND/OR |
| | Over-The-Counter Use<br>(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)

Mana Chan

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k052819