(29 days)
The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.
The Access Rubella IgG reagents consist of reagent packs, calibrators, QC, substrate and wash buffer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Access® Rubella IgG Assay:
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Establishment of substantial equivalence to the legally marketed predicate device (Access Rubella IgG Assay on Access 2 System). | The Access Rubella IgG assay on the Dxl System met the established acceptance criteria for reproducibility and concordance. |
| Acceptable linearity for the Access Rubella IgG assay on the Dxl System. | The assay demonstrated acceptable linearity. |
| Good correlation between the Dxl and Access 2 Systems in a method comparison (linear regression) study using clinical data. | Good correlation was demonstrated. |
Study Details:
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Sample sizes used for the test set and the data provenance: Not explicitly stated. The document mentions "clinical data" but does not specify the number of samples or their country of origin (retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device. The ground truth for this immunoassay device is typically established through a combination of reference methods (e.g., CDC reference assays), serology algorithms, and potentially clinical correlation, rather than expert consensus on images or clinical cases. The document does not provide details on how the ground truth for the "clinical data" used in the method comparison was established.
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Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for qualitative assessments, often in image interpretation, where human readers might disagree. This device is an immunoassay, and its performance is evaluated quantitatively (reproducibility, linearity, correlation).
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an immunoassay device, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study and effects on human reader performance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the described studies (reproducibility, concordance, linearity, method comparison) evaluate the standalone performance of the Access Rubella IgG assay on the Dxl System. The device provides a quantitative result (IgG antibody levels) or a qualitative determination (positive/negative) without human interpretation of raw data in the same way an imaging AI algorithm might be interpreted.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The specific ground truth for the "clinical data" used in the method comparison study is not explicitly detailed. For an immunoassay like this, ground truth for rubella infection and immunity typically relies on established serological reference methods, clinical history, and potentially a combination of IgM and IgG results, rather than pathology or expert consensus on clinical presentation alone. The predicate device (Access 2 System) is implicitly considered a reference standard for the purpose of demonstrating substantial equivalence.
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The sample size for the training set: Not applicable. This device is an immunoassay system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves the development and optimization of reagents and protocols, which is a different process than training an AI model.
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How the ground truth for the training set was established: Not applicable, as there is no "training set" in the AI/ML context for this device.
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1.5 510(K) Summary
(Page 1 of 2)
510(k) Summary
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.
KO3160 510(k) Number _
Date Prepared: May 21,2003
| Submitter | Contact Person |
|---|---|
| Beckman Coulter, Inc | Lynn Weist |
| 1000 Lake Hazeltine Drive | Staff Regulatory Affairs Specialist |
| Chaska, MN 55318 | Phone: 952-368-1271 |
| Fax: 952-368-7710 |
General Information
| Proprietary Name | Access® Immunoassay System Rubella IgG Assay |
|---|---|
| Classification Name | Rubella virus serological reagents |
| Device Class | Class II |
| Legally Marketed (Unmodified)Device | Access Rubella IgG Assay for use on the Access ImmunoassaySystems (K954687, cleared 4/6/96) |
Device Description
The Access Rubella IgG reagents consist of reagent packs, calibrators, QC, substrate and wash buffer.
Intended Use
The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.
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510(k) Summary
Description of the Modification to the Legally Marketed Device
The modification to the Access Rubella IgG assay is to add a new instrument platform, the Beckman Coulter UniCel" Dxl 800 Access® Immunoassay System, to the family of Access Immunoassay Systems. The Dxl System is a new model within the same model series of Access Immunoassay Systems manufactured and distributed by Beckman Coulter, Inc. The Dxl System was cleared for marketing by FDA on January 28, 2003, (K023764).
The DxI uses the same Access Rubella IgG reagents, Calibrators and QC, packaged the same as for the Access 2 System. The formulations of the substrate and wash buffer used with the Access Rubella IgG assay are unchanged. There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assay.
Supporting Data
In order to demonstrate that the Access Rubella IgG assay on the Dxl System is substantially equivalent to the Access Rubella IgG assay on the Access 2 System, reproducibility, concordance and linearity studies were conducted. The Access Rubella IqG assay met the established acceptance criteria for reproducibility and concordance and demonstrated acceptable linearity. A method comparison (linear regression) study completed using clinical data demonstrated good correlation between the DxI and Access 2 Systems.
Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore, 510(k) premarket notification clearance of the Access Rubella IgG Assay on the UniCel Dxl 800 Access Immunoassay System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
JUN 2 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lynn Weist Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K031606
Trade/Device Name: Access Rubella IgG Assay for use on the Access® Immunoassay System Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella Virus Serological Reagents Regulatory Class: Class II Product Code: LFX Dated: May 21, 2003 Received: May 22, 2003
Dear Ms. Weist:
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).
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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.
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). Other general information on your responsibilities under the Act may be obtained 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 Putman
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
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Indications for Use Statement 1.4
510(k) Number (if known): 长۵3 (66 PAGE 1 OF 1
Device Name: Access® Rubella IgG Assay for use on the Access® Immunoassay Systems
Indications for Use:
The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.
(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-Counter Use (Optional Format 1-2-96) | ____________________ |
|---|---|
| ----------------------------------------------- | ---------------------- |
Division Sign-Off
Office of In Vitro Diagnostic DeviceEvaluation and Safety
510(k) K031606
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.