ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

K031857 · Bayer Diagnostics Corp. · DEM · Sep 4, 2003 · Immunology

Device Facts

• Record ID: K031857
• Device Name: ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
• Applicant: Bayer Diagnostics Corp.
• Product Code: DEM · Immunology
• Decision Date: Sep 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Bayer ADVIA Chemistry Alpha-1-antitrypsin assay is an in vitro diagnostic device intended to quantitatively measure Alpha-1-antitrypsin concentration in human serum and plasma on the ADVIA® Chemistry system. Measurement of alpha-1-antitrypsin levels aid in the diagnosis of juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Device Story

In vitro diagnostic assay for quantitative measurement of alpha-1-antitrypsin in human serum and plasma; performed on ADVIA Chemistry system; used in clinical laboratory settings by trained personnel; provides concentration values to clinicians to aid diagnosis of liver cirrhosis and pulmonary emphysema; benefits patient through timely identification of alpha-1-antitrypsin deficiency.

Clinical Evidence

Bench testing only. Correlation study (N=44) comparing ADVIA 1650 to Hitachi AAT system yielded regression equation Y = 0.94x + 13.1 and r=0.965. Imprecision studies showed within-run CVs ranging from 0.83% to 1.1%. Interference testing evaluated hemoglobin, bilirubin, and lipids with recovery ranging from 98.84% to 109.88%. Analytical range established from 5.37 mg/dL to 510 mg/dL.

Technological Characteristics

In vitro diagnostic reagent kit for automated chemistry analyzer. Quantitative immunoturbidimetric assay principle. System is a standalone clinical chemistry analyzer. No specific materials or software architecture details provided.

Indications for Use

Indicated for quantitative measurement of alpha-1-antitrypsin in human serum and plasma to aid in diagnosis of juvenile and adult liver cirrhosis and assessment of 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

• Roche Alpha-1-antitrypsin

Reference Devices

• Hitachi AAT

Submission Summary (Full Text)

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# SEP - 4 2003

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Alpha-1-antitrypsin method for ADVIA® 1650TM

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

The assigned 510(k) number is: KD3/857

## 1. Intended Use

The Bayer ADVIA Chemistry Alpha-1-antitrypsin assay is an in vitro diagnostic device intended to quantitatively measure Alpha-1-antitrypsin concentration in human serum and plasma on the ADVIA® Chemistry system. Measurement of alpha-1-antitrypsin levels aid in the diagnosis of juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

## 2. Predicate Device

| Product Name | Reagent Part # | Calibrator Part # |
|---------------------------|----------------|-------------------|
| Roche Alpha-1-antitrypsin | 1557599 | 1355279 |

## 3. Device / Method

| Product Name | Reagent REF<br>(part #) | Calibrator REF<br>(part #) |
|------------------------------------------------|---------------------------|----------------------------|
| Bayer ADVIA® Chemistry Alpha-<br>1-antitrypsin | 06921866<br>(B01-4834-01) | 07711199<br>(B03-4845-01) |

#### 4. Performance:

| A. Imprecision | | | |
|------------------|-------------------------|------------------|-------------------------|
| ADVIA 1650 | | Roche | |
| Level<br>(ug/dL) | Within-<br>run<br>CV(%) | Level<br>(ug/dL) | Within-<br>run<br>CV(%) |
| 91.83 | 1.1 | 67.5 | 3.9 |
| 188.39 | 0.83 | 496.8 | 0.7 |
| 346.99 | 0.85 | 574.8 | 7.33 |

#### B. Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen Type | Comparison<br>System (x) | N | Regression Equation | Syx | r | Sample Range<br>mg/dL |
|---------------|--------------------------|----|---------------------|------|-------|-----------------------|
| Serum | Hitachi AAT | 44 | $Y = 0.94x + 13.1$ | 20.6 | 0.965 | 42.8 - 258.9 |

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### C. Interfering Substances

| Alpha-1-<br>antitrypsin<br>(ug/dL) | Interferent | Interferent (mg/dL) | Alpha-1-antitrypsin<br>with interferent<br>(mg/dL) | % Recovery |
|------------------------------------|------------------|---------------------|----------------------------------------------------|------------|
| 200.5 | Hemoglobin | 1000 | 220.3 | 109.88% |
| 201.6 | Bilirubin conj | 25 | 207.3 | 102.83% |
| 207.3 | Bilirubin unconj | 25 | 204.9 | 98.84% |
| 204.5 | Intralipid | 125 | 223 | 109.05% |
| 252.8 | TRIG concentrate | 187.5 | 268.9 | 106.37% |

#### D. Analytical Range

Serum/Plasma:

5.37 mg/dL to AAT concentration in highest calibrator (typically 510 mg/dL).

Aula Hues
Andrew Hues

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

6/5/03
Date

Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, New York 10591-5097

SEP - 4 2003

Re: k031857

> Trade/Device Name: Alpha-1-antitrypsin Assay for the ADVIA® Chemistry System Regulation Number: 21 CFR § 866.5130 Regulation Name: Alpha-1-antitrypsin immunological test system Regulatory Class: II Product Code: DEM Dated: August 12, 2003 Received: August 13, 2003

Dear Mr. Holle:

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). 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.

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Page 2 -

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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### 1031857 510(k) Number:

Device Name: Alpha-1-antitrypsin Assay for the ADVIA® Chemistry System

#### Indications for Use:

The Bayer ADVIA Chemistry Alpha-1-antitrypsin method is an in vitro diagnostic device intended to quantitatively measure alpha-1-antitrypsin levels in human serum and plasma. Such measurements are used in the diagnosis of juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> | OR | Over-The-CounterUse |
|------------------------------------------|-----------------------------------------|----|---------------------|
|------------------------------------------|-----------------------------------------|----|---------------------|

(Optional Format 1-2-96)

*[Signature]*

**Division Sign-Off** for *Jean Cooper*

**Office of In Vitro Diagnostic Device**

**Evaluation and Safety**

510(k) k031857