QUANTIA A1-AT

K050596 · Biokit, S.A. · DEM · May 13, 2005 · Immunology

Device Facts

• Record ID: K050596
• Device Name: QUANTIA A1-AT
• Applicant: Biokit, S.A.
• Product Code: DEM · Immunology
• Decision Date: May 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema. Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use. Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.

Device Story

Quantia A1-AT is an in vitro diagnostic reagent kit for quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma; used on Abbott AEROSET® system. Principle of operation is turbidimetry. System requires Quantia PROTEINS Control for quality monitoring and Quantia PROTEINS standard for calibration curve establishment. Used in clinical laboratory settings by trained personnel. Output is concentration value of alpha-1-antitrypsin; assists clinicians in diagnosing liver cirrhosis and pulmonary emphysema. Benefits include standardized, automated measurement of protein levels to support clinical decision-making.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing and a method comparison study. Method comparison against the predicate device (N=111) showed a slope of 1.002 (95% CI: 0.973-1.030) and r=0.9890. Analytical performance included precision (Total %CV 0.8-1.8%), linearity (25-1261 mg/dL), and interference testing (no significant interference from hemoglobin, bilirubin, triglycerides, or turbidity). Matrix comparison confirmed equivalence across serum, Li-Heparin, Li-Heparin with gel, and EDTA samples.

Technological Characteristics

Turbidimetric immunoassay reagent kit. Designed for use on automated clinical chemistry analyzer (Abbott AEROSET®). Includes liquid reagents, calibrators, and controls. Quantitative measurement based on light scattering/turbidity principles.

Indications for Use

Indicated for the quantitative determination of alpha-1 antitrypsin in human serum or plasma to aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema. Prescription use only.

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

• N Antisera to Human alpha-1-Antitrypsin (K860894)

Submission Summary (Full Text)

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K050596

## Section 3 Quantia A1-AT 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

MAY 1 3 2005

Biokit S.A. Can Male, Llissa d'Amunt Barcelona 08186 Spain

#### Contact Person:

Contact: Joan Guixer, Quality Assurance and Regulatory Affairs Director Phone: 34 - 93 860 90 00

#### Summary Prepared:

February 24, 2005

## Name of the device:

Quantia A1-AT

#### Classification name(s):

| 866.5130 | Alpha-1-antitrypsin immunological test system |
|----------|--------------------------------------------------|
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control |

Class II

## ldentification of predicate device(s):

N Antisera to Human alpha-1-Antitrypsin (Dade Behring) K860894

## Description of the device/intended use(s):

The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antityypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.

Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.

Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.

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Statement of Technological Characteristics of the Device Compared to Predicate Device: Quantia A1-AT is substantially equivalent to the commercially available predicate device, N Antisera to Human alpha-1-Antitrypsin, in performance and intended use.

## Summary of Performance Data:

In a method comparison study evaluating 111 samples with alpha-1-antitrypsin levels ranging from 42.0 to 442.5 mg/dL on the Abbott AEROSET® instrument, the slope was 1.002 and the correlation coefficient (r) was 0.9890 for Quantia A1-AT versus the predicate device.

The studies performed on the Abbott AEROSET® system with Quantia A1-AT reagents support the following precision claims:

| Material | Samples<br>/Runs | Mean<br>(mg/dL) | CV(%)<br>Within Run | CV(%)<br>Between<br>Run | CV(%)<br>Total |
|----------------------|------------------|-----------------|---------------------|-------------------------|----------------|
| Low Control<br>(I) | 2/40 | 77.7 | 1.2 | 0.2 | 1.4 |
| Control (I + II) | 2/40 | 156.9 | 0.7 | 0.1 | 0.8 |
| High Control<br>(II) | 2/40 | 229.7 | 1.3 | 0.6 | 1.8 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Public Health Service

Food and Drug Administrati 2098 Gaither Road Rockville MD 20850

# MAY 1 3 2005

Biokit S.A. c/o Ms. Joan Guixer Llissa d'Amunt Barcelona, Spain 08186

Re: k050596

Trade/Device Name: Quantia A1-AT Quantia Proteins Control Quantia Proteins Standard Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha 1-antitrypsin Immunological Test System Regulatory Class: Class II Product Code: DEM, JJS, JJX

Dear Ms. Guixer:

Dated: February 24, 2005 Received: March 8, 2005

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 the Code of Federal Regulations, 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Joan Guixer

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 legally premated 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 contact the Office of Compliance 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,

Robert A. Becker/

Robert L. Becker, Jr., M.D., Ph2 Director

Division of Immunology and Hematology Devices 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): k050596

Device Name: Quantia A1-AT

#### Indications for Use:

The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.

Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.

Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. 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)

Maria M Chan

Division Slan-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K020596