(132 days)
For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW).
One set of four vials, 2 mL each, containing low, intermediate and high levels of progesterone in processed human serum, with preservative, and a progesterone-free sample. The Calibration Verifiers are supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. Stable at 2-8°C for 30 days after opening.
The provided text describes the Siemens IMMULITE®/IMMULITE® 1000 Progesterone Calibration Verification Material (CVM) and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, a detailed study proving device performance, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies as these are typically applicable to diagnostic imaging or AI-driven diagnostic devices.
The document primarily focuses on establishing "substantial equivalence" for a calibration verification material. This type of device's performance validation usually involves demonstrating traceability to a standard, value assignment accuracy, and stability, rather than diagnostic accuracy metrics like sensitivity or specificity.
Here's a breakdown of the available information based on your requested points:
Description of Acceptance Criteria and Device Performance
The core "acceptance criteria" for this device, as described, revolve around traceability, value assignment, and stability. The study proving the device meets these criteria is the "validation following procedures of Siemens Healthcare Diagnostics."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Traceability | The IMMULITE/IMMULITE 1000 Progesterone assay is traceable to an internal standard manufactured using qualified materials and measurement procedures. The CVM is traceable to this standard. |
| Value Assignment | Validated following procedures of Siemens Healthcare Diagnostics. |
| Stability | Unopened: Stable until the expiration date on the vial label. Opened: Stable at 2-8°C for 30 days. (This is compared to the predicate's 14 days, indicating improved stability for the opened device). |
| Substantial Equivalence | The device is deemed "substantially equivalent" to currently marketed devices with similar intended uses, specifically the ADVIA Centaur eE2 Master Curve Material, based on intended use and matrix. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, beyond being "internal standard manufactured using qualified materials and measurement procedures" and human serum used in the CVM. The CVM itself is made with processed human serum.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a calibration verification material, "ground truth" is typically established through reference methods and certified reference materials, not expert consensus on diagnostic images or clinical cases.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods are typically relevant for subjective assessments, such as expert interpretation of medical images or clinical findings, which is not the primary performance metric for a calibration verification material.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers, which is not the nature of this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a diagnostic reagent (calibration verification material), not an algorithm or AI system.
7. The type of ground truth used:
- Traceability to an internal standard: The CVM's values are linked to an internal standard developed using qualified materials and measurement procedures. This internal standard serves as the "ground truth" for the assigned values of the CVM.
8. The sample size for the training set:
- Not applicable/Not specified. As a calibration verification material, it does not involve a "training set" in the context of machine learning or AI. Its development relies on analytical method validation and manufacturing controls.
9. How the ground truth for the training set was established:
- Not applicable. (See #8). The ground truth for the CVM's assigned values is established through its traceability to the internal standard and validated value assignment procedures by Siemens Healthcare Diagnostics.
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APR 2 8 2011
510(k) Summary
Submitter information Contact person: Garo Mimaryan, Regulatory Technical Specialist
Address: Siemens Healthcare Diagnostics, Inc 511 Benedict Avenue Tarrytown, NY 10591
Phone: 914-524-3270 914-524-2601 Fax:
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Date summary prepared: December 17, 2010
Device Trade or Proprietary Name: IMMULITE®/IMMULITE® 1000 Progesterone Calibration Verification Material (CVM)
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.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Predicate Devices:
| Device Name | ADVIA Centaur® Enhanced Estradiol (eE2)Master Curve Material (MCM) |
|---|---|
| Common name | ADVIA Centaur® Enhanced Estradiol (eE2)Master Curve Material (MCM) |
| 510(k) Number | K102904 |
| Manufacturer | Siemens Healthcare Diagnostics |
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Device Description:
IMMULITE/IMMULITE 1000 Progesterone assay is traceable to an internal standard manufactured using qualified materials and measurement procedures. Calibration Verification Material (CVM) is traceable to this standard. One set of four vials, 2 mL each, containing low, intermediate and high levels of progesterone in processed human serum, with preservative, and a progesterone-free sample. The Calibration Verifiers are supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. Stable at 2-8°C for 30 days after opening.
Warnings and Precautions:
For in vitro diagnostic use.
Follow universal precautions, and handle all components as if capable of transmitting infectious agents. Source materials derived from human blood were tested and found nonreactive for syphilis; for antibodies to HIV 1 and 2; for hepatitis B surface antigen; and for antibodies to hepatitis C.
Sodium azide, at concentrations less than 0.1 g/dL, has been added as a preservative. On disposal, flush with large volumes of water to prevent the buildup of potentially explosive metal azides in lead and copper plumbing.
Statement of Intended Use:
For in vitro diagnostic use, for the calibration of the IMMULITE/IMMULITE 1000 Progesterone assay (LKPW).
Performance:
The traceability, value assignment, and stability of the IMMULITE/IMMULITE 1000 Progesterone calibration Verification Material (CVM) has been validated following procedures of Siemens Healthcare Diagnostics. These Progesterone CVMs 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:
| Device | Predicate | |
|---|---|---|
| Item | IMMULITE/IMMULITE 1000Progesterone CVM | ADVIA Centaur eE2 MasterCurve Material |
| Intended Use | For in vitro diagnostic use,for the calibration verificationof the IMMULITE/IMMULITE1000 Progesterone assay(LKPW). | The ADVIA CentaurEnhanced Estradiol MasterCurve Material is for in vitrodiagnostic use in theverification of calibration andreportable range in theADVIA Centaur® EnhancedEstradiol (eE2) assay. |
| Matrix | Human Serum | Same |
| Storage | 2°C to 8°C | Same |
| Stability | Unopened – until expirationdate on the vial label | Same |
Similarities
Differences
| Item | Device | Predicate |
|---|---|---|
| IMMULITE/IMMULITE 1000Progesterone CVM | ADVIA Centaur eE2 MasterCurve Material | |
| Form | Liquid | Lyophilized |
| Analytes | Progesterone | Estradiol |
| Stability | Opened - 30 days | Opened - 14 days |
Conclusions:
The IMMULITE/IMMULITE 1000 Calibration verification Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed ADVIA Centaur eE2 Master Curve Material in intended use and matrix.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of a caduceus, a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics c/o Ernest Joseph 511 Benedict Avenue Tarrytown, NY 10591 USA
APR 2 8 2011
Re: K103683 Trade Name: IMMULITE®/IMMULITE 1000 Progesterone Calibration . Verification Material (CVM) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I. Reserved Product Codes: JJX Dated: April 15, 2011 Received: April 18, 2011
Dear Mr. Joseph:
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 Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney 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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Indication for Use
510(k) Number (if known): K103683
Device Name: the IMMULITE®/IMMULITE 1000 Progesterone Calibration verification Material.
Indication for Use:
For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW).
Prescription Use_X__ And/Or Over the Counter Use _________________________________________________________________________________________________________________________________________________________ ・(21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) .
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
・
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103683
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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.