(178 days)
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No
The device description details a standard turbidimetric immunoassay method, and there are no mentions of AI, ML, or related concepts in the provided text.
No.
This device is an in vitro diagnostic (IVD) test for quantitative determination of a specific substance in human samples, used to aid in diagnosis, not to provide therapy or treatment.
Yes
The device is described as an "Immunological in vitro immunoturbidometric test for the quantitative determination of x -1antitrypsin in human serum and plasma" and states that "The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver." This clearly indicates its use in diagnosing medical conditions.
No
The device description clearly outlines a laboratory-based in vitro diagnostic test that utilizes chemical reagents and measures turbidity. This involves physical components and processes beyond software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "Immunological in vitro immunoturbidometric test for the quantitative determination of x -1antitrypsin in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The device uses "human serum and plasma," which are biological samples taken from the body but tested outside of it. This is characteristic of IVDs.
- Purpose: The test is used to "aid in the diagnosis of several conditions," which is a primary function of IVDs.
- Device Description: The description details a laboratory-based test using reagents (TRIS buffer solution, polyclonal anti-human α -1-antitrypsin antibodies) to analyze a sample and produce a result (turbidity measurement). This is consistent with how IVDs function.
N/A
Intended Use / Indications for Use
Immunoturbidometric assay for the quantitative in-vitro determination of alpha -1-antitrypsin.
Immunological in vitro immunoturbidometric test for the quantitative determination of alpha -1-antitrypsin in human serum and plasma.
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.
Product codes (comma separated list FDA assigned to the subject device)
DEM
Device Description
The alpha -1-antitrypsin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing alpha -1-antitrypsin is transferred into a TRIS buffer solution (R1 reagent). In the second step, an aliquot of solution of polyclonal anti-human alpha -1-antitrypsin antibodies (R2 reagent) is added to mixture of the first step. The antibody will bind to the alpha -1-antitrypsin in the sample to form “aggregates” such that the amount of aggregate formed is proportionate to the amount of alpha -1-antitrypsin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of alpha-1-antitrypsin in the sample is directly proportional to the amount of turbidity formed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Intra-Assay (N=21):
- Low Level: Mean 155.7, %CV 3.1
- Pool Level: Mean 167.1, %CV 2.5
- High Level: Mean 311.9, %CV 2.5
Inter-Assay:
- Sample 1: Mean 160.7, %CV 2.1
- Sample 2: Mean 307.3, %CV 2.0
Lower Detection Limit: 10 mg/dL
Method Comparison:
Vs Behring BN alpha -1-Antitrypsin:
- Passing/Bablok: y = 0.993x + 9.9, r = 0.967, SEE = 9.7, N = 123
- Least Squares: y = 0.971x + 12.2, r = 0.967, SEE = 11.4, N = 123
Interfering substances (No interference at
§ 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
Telephone: +1 (510) 674 0667 Fax: +1 (510) 674 1680
Boehringer Mannheim Corporation Laboratory Diagnostics 2400 Bisso Lañe PO Box 4117 Concord CA 94524-4117
Image /page/0/Picture/4 description: The image shows the date "JAN - 9 1998" in bold, black font. The month is abbreviated to "JAN", followed by a hyphen, the number 9, and the year 1998. The text is clear and easily readable against the white background. There is also a black rectangle on the right side of the image.
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction According to the requirements.issderstand the basis for a determination of substantial equivalence.
- Submitter name, address, contact
Boehringer Mannheim Corporation 135 Sandberg Street Thousand Oaks, CA 91360 (805) 241 - 7575
Contact Person: Mary Koning
Date Prepared: July 13, 1997
Proprietary name: Tina-quant® a -1-Antitrypsin Assay
- Device name
Common name: Immunoturbidometric assay for the determination of x -1antitrypsin.
Classification name: α -1-antitrypsin immunological test system
- Predicate device
The Boehringer Mannheim Tina-quant® a-1-Antitrypsin is substantially The Dochings Maximal in commercial distribution intended for similar cquivalent to other processionially equivalent to the currently marketed Behring BN® α-1-Antitrypsin assay.
Continued on next page
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510(k) Summary, Continued
| 4. Device Description | The α -1-antitrypsin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing α -1-antitrypsin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human α -1-antitrypsin antibodies (R₂ reagent) is added to mixture of the first step. The antibody will bind to the α -1-antitrypsin in the sample to form “aggregates” such that the amount of aggregate formed is proportionate to the amount of α -1-antitrypsin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of α-1-antitrypsin in the sample is directly proportional to the amount of turbidity formed. |
|---|---|
| 5. Intended use | Immunoturbidometric assay for the quantitative in-vitro determination of α -1-antitrypsin. |
| 6. Comparison to predicate device | The Boehringer Mannheim Tina-quant® α -1-antitrypsin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring BN® α -1-Antitrypsin assay. |
| Continued on next page |
Continued on next page
.
2
510(k) Summary, Continued
- Comparison to predicate device cont.
The following table compares the Tina-quant® α-1-Antitrypsin with the on a I he following table compares the 11-Antitrypsin assay. Specific data on the predicate device, Belling Brive of the consided into the draft labeling in performance of the test have been incorporated into the the the more of the more of the management 6.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination of α - 1-antitrypsin
·Sample type: Serum and plasma
Differences
| Feature | Tina-quant® α-1-
Antitrypsin | Behring BN® α -1-
Antitrypsin |
|----------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------|
| Reaction test
principle | Immunoturbidimetric | Latex bound antigen/antibody
causing visible agglutination
throught large immune complex
formation. |
| Instrument
required | Hitachi | Behring Nephelometer (BN) |
Performance Characteristics:
| Feature | Tina-quant® α-1-
Antitrypsin | | | Behring BN® α -1-
Antitrypsin | |
|-------------|---------------------------------|----------|----------|----------------------------------|-----|
| Precision | Intra and InterAssay (mg/dl): | | | Within and Between (mg/dL): | |
| | Level | Low | Pool | High | |
| Intra-Assay | N | 21 | 21 | 21 | 700 |
| | Mean | 155.7 | 167.1 | 311.9 | 244 |
| | %CV | 3.1 | 2.5 | 2.5 | 3.7 |
| | Level | Sample 1 | Sample 2 | | |
| Inter-Assay | Mean | 160.7 | 307.3 | | 244 |
| | %CV | 2.1 | 2.0 | | 5.3 |
Continued on next page
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510(k) Summary, Continued
Performance Characteristics:
Comparison
to predicate
device, (cont.)
| Feature | Tina-quant® α-1-
Antitrypsin | Behring BN® α -1-
Antitrypsin |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Lower Detection
Limit | 10 mg/dL | - 30 mg/dL |
| Method
Comparison | Vs Behring BN® α -1-
Antitrypsin
Passing/Bablok
y =0.993x + 9.9
r=0.967
SEE =9.7
N=123
Least Squares:
y = 0.971x + 12.2
r = 0.967
SEE = 11.4
N = 123 | Vs Behring LN® α -1-
Antitrypsin
Linear Regression
y =0.88x + 30.2
r=0.967
N=59 |
| Interfering
substances | No interference at:
(≤ 10% error)
Bilirubin 60 mg/dL
Hemoglobin 1000 mg/dL
Lipemia 1000 mg/dL
Rheumatoid
Factor 100 IU/mL | N/A |
| Specificity | Specific for α -1-antitrypsin | Specific for α -1-antitrypsin |
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Image /page/4/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 lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 9 1998
Ms. Mary Koning Regulatory Affairs Specialist Boehringer Mannheim Corporation 135 Sandberg Street Thousand Oaks, California 91360
Re: K972640/S1 Trade Name: Tina-quant® α -1-Antitrypsin Assay Regulatory Class: II Product Code: DEM Dated: October 20, 1997 Received: October 22, 1997
Dear Ms. Koning:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, goodmanufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K972640
Device Name: Tina-quant® x - 1-antitrypsin Assay
Indications For Use:
Immunological in vitro immunoturbidometric test for the quantitative determination of x -1antitrypsin in human serum and plasma.
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.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972648 |