(80 days)
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Not Found
No
The summary describes a quantitative in vitro diagnostic assay for measuring Alpha-1-antitrypsin levels. The performance studies focus on traditional analytical metrics like imprecision, correlation, and interference, with no mention of AI/ML algorithms, image processing, or training/test sets typically associated with such technologies in medical devices.
No
This device is an in vitro diagnostic device used to measure alpha-1-antitrypsin levels, which aids in diagnosis. It does not provide treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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." This directly indicates its role in diagnosis.
No
The device is an in vitro diagnostic assay, which is a chemical reagent kit used with a specific hardware system (ADVIA Chemistry system) to measure a substance in biological samples. This inherently involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DEM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
juvenile and adult
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A. Imprecision: ADVIA 1650 showed within-run CV(%) of 1.1% at 91.83 ug/dL, 0.83% at 188.39 ug/dL, and 0.85% at 346.99 ug/dL. Roche showed within-run CV(%) of 3.9% at 67.5 ug/dL, 0.7% at 496.8 ug/dL, and 7.33% at 574.8 ug/dL.
B. Correlation: For Serum, compared to Hitachi AAT (x) with N=44, the regression equation was Y = 0.94x + 13.1, Syx=20.6, r=0.965. Sample Range: 42.8 - 258.9 mg/dL.
C. Interfering Substances:
- Hemoglobin (1000 mg/dL): 109.88% recovery (AAT with interferent: 220.3 mg/dL from 200.5 mg/dL)
- Bilirubin conj (25 mg/dL): 102.83% recovery (AAT with interferent: 207.3 mg/dL from 201.6 mg/dL)
- Bilirubin unconj (25 mg/dL): 98.84% recovery (AAT with interferent: 204.9 mg/dL from 207.3 mg/dL)
- Intralipid (125 mg/dL): 109.05% recovery (AAT with interferent: 223 mg/dL from 204.5 mg/dL)
- TRIG concentrate (187.5 mg/dL): 106.37% recovery (AAT with interferent: 268.9 mg/dL from 252.8 mg/dL)
D. Analytical Range: Serum/Plasma: 5.37 mg/dL to AAT concentration in highest calibrator (typically 510 mg/dL).
Key Metrics
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Predicate Device(s)
Roche Alpha-1-antitrypsin
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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
(part #) | Calibrator REF
(part #) |
|------------------------------------------------|---------------------------|----------------------------|
| Bayer ADVIA® Chemistry Alpha-
1-antitrypsin | 06921866
(B01-4834-01) | 07711199
(B03-4845-01) |
4. Performance:
| A. Imprecision | |||
|---|---|---|---|
| ADVIA 1650 | Roche | ||
| Level | |||
| (ug/dL) | Within- | ||
| run | |||
| CV(%) | Level | ||
| (ug/dL) | Within- | ||
| run | |||
| 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
System (x) | N | Regression Equation | Syx | r | Sample Range
mg/dL |
|---------------|--------------------------|----|---------------------|------|-------|-----------------------|
| Serum | Hitachi AAT | 44 | $Y = 0.94x + 13.1$ | 20.6 | 0.965 | 42.8 - 258.9 |
1
C. Interfering Substances
| Alpha-1-
antitrypsin
(ug/dL) | Interferent | Interferent (mg/dL) | Alpha-1-antitrypsin
with interferent
(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
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple, yet recognizable, and is used to represent the department's mission to protect the health of all Americans and provide essential human services.
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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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 (301) 594-3084. 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,
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
4
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
| (Per 21 CFR 801.109) | ✓ | 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