(147 days)
In vitro diagnostic reagents for the quantitative determination of a -antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometery on the BN™ Systems. The measurement of a-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a r-antitrypsin deficiency has been associated with pulmonary emphysema in conjunction with other laboratory and clinical findings.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes statter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
This document describes the N Antisera to Human α-Antitrypsin Assay, an in vitro diagnostic reagent for the quantitative determination of alpha-1-antitrypsin (α1-AT) in human serum, heparinized, and EDTA plasma using immunonephelometry on the BN™ Systems.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for a specific performance metric. Instead, the "device performance characteristics" section in the K053072 summary focuses on demonstrating equivalence in measurement between different sample types (serum, heparinized plasma, and EDTA plasma) and to a legally marketed predicate device.
The reported device performance is based on method comparison studies:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in measurement between serum and heparinized or EDTA plasma. | Correlation coefficients between 0.97 and 0.99 for method comparisons. |
| Substantial equivalence to the predicate device (N Antisera to Human α-Antitrypsin, K860894). | The modified assay demonstrated equivalent performance to the predicate device for quantitative determination of α-antitrypsin by immunonephelometry on BN™ Systems. |
Study Proving Acceptance Criteria:
The study proving the device meets its implied acceptance criteria of equivalence was a method comparison study.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the test set used in the method comparison studies. It only states that "method comparisons were performed."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that the manufacturer is based in Germany (Dade Behring Marburg GmbH) and the contact information for regulatory submission is in the US (Dade Behring Inc.), the data could be from various global sites.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is an in vitro diagnostic reagent for quantitative measurement of a biomarker. The "ground truth" for method comparison studies would typically be the results obtained from a reference method or the established predicate device, not expert consensus on qualitative interpretation.
4. Adjudication Method:
Not applicable. As described above, this is a quantitative measurement, and adjudication by experts is not a relevant component of its validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. An MRMC study is relevant for devices that involve human interpretation of images or other qualitative data, particularly in the context of diagnostic accuracy. This device is an automated quantitative reagent.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted in the sense that the device's analytical performance (specifically, its ability to yield comparable quantitative results across different sample matrices) was evaluated intrinsically. The method comparison studies demonstrated the performance of the algorithm/reagent by itself in generating the quantitative alpha-1-antitrypsin values. This means the analytical performance of the device without human interpretation was assessed.
7. Type of Ground Truth Used:
The "ground truth" for the method comparison studies would be the quantitative results obtained from:
- Measurements using the predicate device (N Antisera to Human α-Antitrypsin, K860894), for establishing substantial equivalence.
- Measurements from serum samples when comparing performance with heparinized and EDTA plasma. This implies that serum is considered the primary, well-established matrix for α1-AT determination against which other matrices are compared.
8. Sample Size for the Training Set:
Not applicable. This device is a reagent for an immunonephelometry system. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The "training" of such a system would involve calibration curves and reagent optimization, which are part of the manufacturing and method development process, not a distinct training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration and optimization of the reagent and system would follow established laboratory practices for IVD assays, using certified reference materials or well-characterized control sera with known α1-AT concentrations to establish calibration curves. This is an analytical validation process, not a ground truth establishment for a training set.
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MAR 2 8 2006
510(k) Summary for N Antisera to Human αィ-Antitrypsin
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K05
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
October 28, 2005
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- Device Name/ Classification: N Antisera to Human α-Antitrypsin Class: a4-Antitrypsin Immunological Test System, Class II, 21 CFR 866.5130 Panel: Immunology Product Code: DEM
3. ldentification of the Legally Marketed Device:
N Antisera to Human a - Antitrypsin - K860894
4. Device Description:
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes statter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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5. Device Intended Use:
In vitro diagnostic reagents for the quantitative determination of a-antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometry on the BN™ Systems.
Medical device to which equivalence is claimed and comparison information: 6.
The modified N Antisera to Human a -- Antitrypsin assay is substantially equivalent to the N Antisera to Human a - Antitrypsin currently marketed (K860894). The modified N. Antisera to Human a - Antitrypsin assay, like the current N Antisera to Human a - Antitrypsin assay, is intended for the quantitative determination of a - antitrypsin by means of immunonephelometry on the BN™ Systems.
7. Device Performance Characteristics:
To demonstrate equivalence in measurement between serum and heparinized or EDTA plasma, method comparisons were performed. The studies demonstrate equivalent performance with correlation coefficients between 0.97 and 0.99
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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 stripes representing the department's mission to promote health, well-being, and human services. The text "HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 8 2006
Dade Behring, Inc. c/o Ms. Kathleen A Dray-Lyons Glasgow Site P.O. Box 6101 Newark, DE 19714
Re: K053072
Trade/Device Name: N Antisera to Human al-Antitrypsin Assay Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1-Antitrypsin Immunological Test System Regulatory Class: Class II Product Code: DEM Dated: October 28, 2005 Received: November 1, 2005
Dear Ms. Dray-Lyons:
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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This letter will allow you to begin marketing your device as described in vour 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Robert A. Becker/
Robert L. Becker, Jr., M.D., Ph.D. 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 Statement
Device Name:
N Antisera to Human α - Antitrypsin Assay
Indications for Use:
In vitro diagnostic reagents for the quantitative determination of a -antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometery on the BN™ Systems. The measurement of a-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a r-antitrypsin deficiency has been associated with pulmonary emphysema in conjunction with other laboratory and clinical findings.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria Chan
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Livision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
053072
§ 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).