(66 days)
No
The summary describes a quantitative immunoassay for alpha-1-antitrypsin using turbidimetry on a specific instrument. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on method comparison and precision, which are standard for this type of assay.
No
The device is described as an in vitro diagnostic (IVD) device used for the quantitative determination of alpha-1-antitrypsin concentration as an aid in diagnosis, not for treating or providing therapy.
Yes The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma... as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema."
No
The device description explicitly states it is a reagent kit (Quantia A1-AT, Quantia PROTEINS Control, Quantia PROTEINS standard) used for in vitro diagnostic testing on a specific hardware system (AEROSET® system). This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the device is "intended for the in vitro quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma... as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema." The phrase "in vitro" and the use of human biological samples for diagnostic purposes are key indicators of an IVD.
- Device Description: The description reiterates the "in vitro quantitative determination" and the use of human serum or plasma.
- Quantia PROTEINS Control and Standard: The descriptions for the control and standard also state "For in vitro diagnostic use."
- Predicate Device: The predicate device listed (N Antisera to Human alpha-1-Antitrypsin) is also an IVD, which is a strong indicator that the subject device is in the same category.
N/A
Intended Use / 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.
Product codes
DEM, JJS, JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
juvenile and adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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/Runs | Mean(mg/dL) | CV(%) Within Run | CV(%) Between Run | CV(%) Total |
|---|---|---|---|---|---|
| Low Control(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(II) | 2/40 | 229.7 | 1.3 | 0.6 | 1.8 |
Key Metrics
Correlation coefficient (r) was 0.9890.
Precision claims:
Low Control (I): Mean 77.7 mg/dL, CV(%) Within Run 1.2, CV(%) Between Run 0.2, CV(%) Total 1.4
Control (I + II): Mean 156.9 mg/dL, CV(%) Within Run 0.7, CV(%) Between Run 0.1, CV(%) Total 0.8
High Control (II): Mean 229.7 mg/dL, CV(%) Within Run 1.3, CV(%) Between Run 0.6, CV(%) Total 1.8
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -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.(b)
Classification. Class II (performance standards).
0
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.
1
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
/Runs | Mean
(mg/dL) | CV(%)
Within Run | CV(%)
Between
Run | CV(%)
Total |
|----------------------|------------------|-----------------|---------------------|-------------------------|----------------|
| Low Control
(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
(II) | 2/40 | 229.7 | 1.3 | 0.6 | 1.8 |
2
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.
3
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 (240) 276-0131. 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 (800) 638-2041 or (301) 443-6597 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
4
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