(53 days)
The ADVIA Centaur® Cyclosporine Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Cyclosporine (CsA) assay.
The ADVIA Centaur® Cyclosporine Master Curve Material are 5 level human serum based solutions containing varying concentrations of cyclosporine in human serum, bused offerents, glycerol, anti-foam and preservatives. The Cyclosporine Master Curve deterials have expected values (lot specific) of 0, 100, 500, 900 and 1400 ng/mL.
The Cyclosporine Master Curve Material (1.0 mL/vial) are liquid and ready to use. Storage is at 2 - 8ºC.
CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDA-Scrum or plashia censi frind nonreactive for hepatitis B surface antigen (HBsAg), antibody to approvou mothous and rotibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer matchan once that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ADVIA Centaur® Cyclosporine Master Curve Material.
It's important to note that this document is a 510(k) summary for a medical device (a control material for an immunoassay), not an AI/ML powered diagnostic device. Therefore, many of the requested fields (such as MRMC studies, number of experts for ground truth, sample size for training set, etc.) are not applicable in this context. The "performance" section primarily focuses on technical validation of the control material itself, rather than diagnostic accuracy against a disease state.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the ADVIA Centaur® Cyclosporine Master Curve Material does not explicitly provide a table of acceptance criteria in the traditional sense of a diagnostic device (e.g., target sensitivity, specificity). Instead, it describes the validation of the material's properties, which effectively serve as the performance characteristics for this type of device.
| Performance Characteristic/Acceptance Criteria | Reported Device Performance (as described) |
|---|---|
| Traceability | Validated following Siemens Master Curve Materials procedures. |
| Value Assignment | Validated following Siemens Master Curve Materials procedures. Expected values: 0, 100, 500, 900, 1400 ng/mL (lot specific). |
| Stability (Unopened) | Validated following Siemens Master Curve Materials procedures. Until expiration date on the vial label. |
| Stability (Opened) | Validated following Siemens Master Curve Materials procedures. 21 weeks. |
| Stability (On-board) | Validated following Siemens Master Curve Materials procedures. 4 hours. |
| Form | Liquid and ready to use. |
| Matrix | Human Serum based. Contains human source material. |
| Storage Conditions | 2 - 8ºC. |
| Intended Use Fulfilled | For in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Cyclosporine (CsA) assay. |
| Biohazard Testing | Each human serum or plasma donor unit tested by FDA-approved methods and found nonreactive for HBsAg, antibody to HCV, and antibody to HIV-1/2. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set sample size" in the conventional diagnostic sense (i.e., a number of patient cases tested). The validation described pertains to the control material itself.
- Test Set: Not applicable as a patient-based test set. The material itself is the subject of testing for its properties.
- Data Provenance: The document implies internal validation by Siemens Healthcare Diagnostics. No country of origin for specific "data" is mentioned, nor is it specified if the validation was retrospective or prospective. It would be prospective in nature for a new manufacturing lot.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a control material, "ground truth" is established by manufacturing and analytical processes (e.g., gravimetric preparation, reference methods, stability studies), not by expert medical interpretation of cases.
4. Adjudication Method for the Test Set
Not applicable, as there's no diagnostic test set requiring adjudication.
5. 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 device is a control material for an in vitro diagnostic assay, not an AI/ML powered diagnostic device. No human readers or AI assistance are involved in its performance or evaluation as described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a biochemical control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the ADVIA Centaur® Cyclosporine Master Curve Material is established through analytical reference methods and manufacturing specifications. Specifically:
- Manufacturing Specifications: The materials are prepared to contain "varying concentrations of cyclosporine" with "expected values (lot specific) of 0, 100, 500, 900 and 1400 ng/mL." This implies the "true" concentration levels are known based on the meticulous preparation process.
- Traceability and Value Assignment: These processes (as stated: "validated following procedures of Siemens Master Curve Materials") would involve established methods and possibly certified reference materials to assign the target values accurately.
- Stability Studies: These establish the ground truth regarding how long the material maintains its assigned values under different storage conditions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML product.
Summary of the Study Proving Device Meets Acceptance Criteria
The study described is an internal validation process conducted by Siemens Healthcare Diagnostics for their ADVIA Centaur® Cyclosporine Master Curve Material. The performance section states:
"The traceability, value assignment, and stability of the ADVIA Centaur® Cyclosporine Master Curve Materials have been validated following procedures of Siemens Master Curve Materials."
This indicates that Siemens Healthineers has established internal protocols and procedures for ensuring the quality, accuracy, and shelf-life of their control materials. These procedures would involve:
- Manufacturing Control: Precise formulation of the control material to achieve the stated cyclosporine concentrations (0, 100, 500, 900, and 1400 ng/mL).
- Analytical Verification: Using established analytical methods (likely on the ADVIA Centaur Cyclosporine assay itself, and potentially against external reference methods) to confirm the assigned values for each lot.
- Stability Studies: Protocols simulating long-term storage (unopened), short-term storage (opened), and on-board usage conditions to determine how long the material maintains its integrity and assigned values within acceptable limits. This would involve repeat testing over time intervals.
- Biohazard Testing: Screening of all human source material used in the controls for infectious agents (HBsAg, HCV, HIV-1/2) using FDA-approved methods.
The conclusion drawn from these internal validations is that the device is "substantially equivalent to other products in commercial use of a similar use" and "substantially equivalent to the predicate device," meaning it performs comparably and safely for its intended purpose as a calibration and reportable range verification material.
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510(k) Summary
NOV 2 0 2009
| Submitter information Contact person: | Clare SantulliSr. Regulatory Technical Specialist |
|---|---|
| Address: | Siemens Healthcare Diagnostics, Inc511 Benedict AvenueTarrytown, NY 10591 |
| Phone: | 914-524-2701914-524-3579 (fax) |
| Date summary prepared: | September 24, 2009 |
| Device Trade or Proprietary Name: | ADVIA Centaur® Cyclosporine Master Curve Material |
| Device Common/Usual Name or Classification Name: | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Classification Number/Class: | JJX / Class I |
| Classification Panel: | Clinical Chemistry (75) |
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
Ko 92993 The assigned 510(k) number is: __
Predicate Devices:
| Device Name | VALIDATE Thyroid Calibration Verification Test Set |
|---|---|
| Common name | VALIDATE THY Calibration Verification Test Set |
| 510(k) Number | K062501 |
| Manufacturer | Maine Standards Company |
Siemens Healthcare Diagnostics, Inc Stemens Nealthcare Diagnostios, The Materials Premarket Notification - Abbreviated 510(k) September 2009
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Device Description:
The ADVIA Centaur® Cyclosporine Master Curve Material are 5 level human serum based solutions containing varying concentrations of cyclosporine in human serum, bused offerents, glycerol, anti-foam and preservatives. The Cyclosporine Master Curve deterials have expected values (lot specific) of 0, 100, 500, 900 and 1400 ng/mL.
The Cyclosporine Master Curve Material (1.0 mL/vial) are liquid and ready to use. Storage is at 2 - 8ºC.
CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDA-Scrum or plashia censi frind nonreactive for hepatitis B surface antigen (HBsAg), antibody to approvou mothous and rotibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer matchan once that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.
Statement of Intended Use:
The ADVIA Centaur® Cyclosporine Master Curve Material is for in vitro diagnostic use in the rne ADVIA Ochlibration and reportable range in the ADVIA Centaur® Cyclosporine (CSA) assay.
Performance:
The traceability, value assignment, and stability of the ADVIA Centaur® Cyclosporine Master Curve Materials have been validated following procedures of Siemens Master Ourve Materials . These Cyclosporine Master Curve Material are substantially equivalent to currently marketed devices with similar intended uses.
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Comparison to the Predicate Device:
Similarities and Differences between the devices and the predicate are shown below:
Comparison Table*
| Device | Predicate | |
|---|---|---|
| Item | ADVIA Centaur Master CurveMaterial | Maine Standards CompanyVALIDATE Thyroid CalibrationVerification Test Set(K062501) |
| Intended Use | The ADVIA Centaur®Cyclosporine Master CurveMaterial is for in vitro diagnosticuse in the verification ofcalibration and reportable rangein the ADVIA Centaur®Cyclosporine (CsA) assay. | The VALIDATE ThyroidCalibration Verification Test Setsolutions are for in vitrodiagnostic use in the quantitativedetermination of linearity,calibration verification andverification of reportable range inautomated, semi-automated andmanual chemistry systems. |
| Form | Liquid | Liquid |
| Analytes | Cyclosporine only | Multiple analytes includingTriiodothyronine (Ta), Thyroxineff4), human Thyroid StimulatingHormone (TSH), and Cortisol |
| Matrix | Human Serum | Human Serum |
| Storage | 2°C to 8°C | -10°C to -20°C |
| Stability | Unopened - until expiration dateon the vial labelOpened - 21 weeksorOn-board - 4 hours | Unopened - until expiration dateon storage container when storedas directed |
| Differences | Verification of calibration andreportable range for the ADVIACentaur® Cyclosporine assay. | Verification of calibration,linearity, and reportable range formultiple assays (Triiodothyronine(Ta), Thyroxine ff4), humanThyroid Stimulating Hormone(TSH), and Cortisol) |
- From Instructions for Use
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Conclusions:
The ADVIA Centaur® Cyclosporine Master Curve Material is substantially equivalent to other The ADVIA Centadi "Oyclosponne Master of arromilar use. Most notably, it is substantially, products in commercial uismodion interiod for enniker company, lite equivalent to the contonity marketse mains essent to the stability.
Siemens Healthcare Diagnostics, Inc Olemens Houldsporine Master Curve Materials Premarket Notification - Abbreviated 510(k) September 2009
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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized symbol. The symbol is a representation of a stylized bird or eagle, with three curved lines forming its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Siemens Healthcare Diagnostics, Inc. c/o Ms. Clare Santulli Senior Regulatory Technical Specialist 511 Benedict Avenue Tarrytown, NY 10591
NOV 2 0 2009
Re: K092993
Trade Name: ADVIA Centaur® Cyclosporine Master Curve Material Regulation Number: 21 CFR §862.1660 . Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: November 12, 2009 Received: November 16, 2009
Dear Ms. Santulli:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K092993 |
|---|---|
| --------------------------- | --------- |
ADVIA Centaur® Cyclosporine Master Curve Material Device Name(s):
Indications For Use:
The ADVIA Centaur® Cyclosporine Master Curve Material is for in vitro diagnostic use in the THE ADVIA Centaur® Oyclosponing mater San J. San J. Santaur® Cyclosporine (CSA) assay.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
Page 1 of 1
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.