(53 days)
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No
The document describes a calibration material for a laboratory assay, not a device that processes data or makes decisions using AI/ML.
No.
This device is an in vitro diagnostic product used for the verification of calibration and reportable range of another assay, not for directly treating a medical condition.
No
Explanation: The device is described as "Master Curve Material" for in vitro diagnostic use in the "verification of calibration and reportable range" of an assay, not for directly diagnosing a condition in a patient. It is used to ensure the accuracy of a diagnostic assay.
No
The device description clearly states it is a "human serum based solution" and a "liquid and ready to use" material, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "for in vitro diagnostic use".
- Device Description: The device is a "human serum based solution" containing varying concentrations of cyclosporine, designed to be used in the "ADVIA Centaur® Cyclosporine (CsA) assay". This describes a reagent used in a laboratory test performed outside of the body (in vitro).
- Purpose: The purpose is for "verification of calibration and reportable range" in a diagnostic assay. This is a quality control material used to ensure the accuracy of a diagnostic test.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Cyclosporine Master Curve Material is for in vitro diagnostic use in the ADVIA Centaur® Cyclosporine (CSA) assay.
Product codes
JJX
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.
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
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) Summary
NOV 2 0 2009
| Submitter information Contact person: | Clare Santulli
Sr. Regulatory Technical Specialist |
|--------------------------------------------------|-----------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics, Inc
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-524-2701
914-524-3579 (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
1
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.
2
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 Curve | |
| Material | Maine Standards Company | |
| VALIDATE Thyroid Calibration | ||
| Verification Test Set | ||
| (K062501) | ||
| Intended Use | 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 VALIDATE Thyroid | |
| Calibration Verification Test Set | ||
| solutions are for in vitro | ||
| diagnostic use in the quantitative | ||
| determination of linearity, | ||
| calibration verification and | ||
| verification of reportable range in | ||
| automated, semi-automated and | ||
| manual chemistry systems. | ||
| Form | Liquid | Liquid |
| Analytes | Cyclosporine only | Multiple analytes including |
| Triiodothyronine (Ta), Thyroxine | ||
| ff4), human Thyroid Stimulating | ||
| Hormone (TSH), and Cortisol | ||
| Matrix | Human Serum | Human Serum |
| Storage | 2°C to 8°C | -10°C to -20°C |
| Stability | Unopened - until expiration date | |
| on the vial label |
Opened - 21 weeks
or
On-board - 4 hours | Unopened - until expiration date
on storage container when stored
as directed |
| Differences | Verification of calibration and
reportable range for the ADVIA
Centaur® Cyclosporine assay. | Verification of calibration,
linearity, and reportable range for
multiple assays (Triiodothyronine
(Ta), Thyroxine ff4), human
Thyroid Stimulating Hormone
(TSH), and Cortisol) |
- From Instructions for Use
3
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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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