(190 days)
Not Found
No
The summary describes a calibration verification material for an immunoassay system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on stability and traceability of the calibration material.
No
This device is described as a "Calibration Material" intended for "monitoring system performance" of an immunoassay system. It does not directly treat or diagnose a disease or condition in a patient, which are functions of a therapeutic device. Instead, it ensures the accuracy of another device that may be used in diagnosis.
No
This device is a calibration material used to monitor the performance of an immunoassay system, not a diagnostic device itself.
No
The device description clearly states it contains physical vials of material (bovine protein/buffer matrix, human-source matrix with Free PSA) in lyophilized form. This is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: It describes a material containing Free PSA antigen in a matrix, designed to be used with an immunoassay system. This is consistent with the nature of IVD calibration or verification materials.
- Performance Studies: The document details performance studies related to stability and value assignment, which are typical for IVD devices to ensure they function correctly.
- Traceability: It mentions traceability to a WHO standard, which is a common requirement for IVD devices to ensure accuracy and comparability.
- Value Assignment: The description of value assignment and expected ranges further confirms its role in the diagnostic process.
- Predicate Device: The mention of a predicate device (K131536; IMMULITE® 2000 PSA Calibration Verification Material) which is also a calibration verification material, strongly suggests this device falls under the same regulatory category as an IVD.
While it doesn't directly measure a patient sample, it is a critical component used with an IVD system to ensure the accuracy and reliability of the diagnostic results obtained from patient samples. Therefore, it is considered an IVD itself.
N/A
Intended Use / Indications for Use
The IMMULITE® Free PSA Calibration Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen.
Product codes
JJX
Device Description
IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) contains one set of four vials (LPFCVM1-4), 2 mL each. LPFCVM1 contains bovine protein/buffer matrix with preservatives. LPFCVM2, LPFCVM3 and LPFCVM4 contain low, intermediate and high levels of Free PSA respectively, in human-source matrix with preservatives. The CVMs are supplied lyophilized form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the candidate device.
Stability Summary:
The stability study was conducted to validate the shelf life claim for the IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platform throughout the established shelf life of the CVM. The IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) stability study performed with CVM lot 15 shows acceptable results up to 3.5 years when stored at -20°C, and for on-going stability for lots 90 and 91 shows acceptable results up to 6 months at this time when stored at -20°C. Therefore the current shelf life stability claim is 6 months.
Stability Protocol Summary:
The CVMs are run as part of the calibrator stability testing. The stability calibrators/CVMs are run in duplicate (as a minimum) and the concentration value is determined from the reference internal calibration curve. Stability calibrators/CVMs are run at 6 months then annually up to the month after expiry. The stability will be tested at 24, 36 and 42 months.
Value Assignment, Expected Values and Reference Range:
Free PSA CVMs are 4 level materials which are subset of 11 level Free PSA calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of Free PSA reagents and two point adjustors. The IMMULITE calibrators and therefore CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using Free PSA antigen stock and are traceable to internal material which has been gravimetrically prepared. Three levels of commercially available controls and 20 normal male patient samples, 10 spiked samples and 10 PSA patient samples were used to validate CVM value assignments.
The Free PSA CVM level were tested on 18 replicates in total comprised of 6 runs and 3 replicates per run on 4 IMMULITE 2000 system analyzers and 2 different reagent kit lots. The CVM values are calculated based on the recovered values for each run on each instrument independently. CVM values are then averages across all systems. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected assay range is 0.07 - 25.0 ng/mL. The controls must fall within their target ranges.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Free PSA Calibration Verification Material (CVM) requires that the dose concentration for the stability CVM is within 10% of assigned dose concentration.
| CVM Level | Assigned Dose (ng free PSA/mL) | Acceptance Criteria (% difference to assigned dose) | Acceptable Range (ng free PSA/mL) |
|---|---|---|---|
| LPFCVM1 | 0.00 | N/A | N/A |
| LPFCVM2 | 0.20 | +10 | 0.18 - 0.22 |
| LPFCVM3 | 1.45 | +10 | 1.31 - 1.60 |
| LPFCVM4 | 24.40 | +10 | 21.96 - 26.84 |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SIEMENS
510(k) Summary
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K133816
| 1. | Submitter
Mailing Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 |
|----|-------------------------------|-----------------------------------------------------------------------------------|
| | Contact Person: | Ernest Joseph
Senior Manager, Regulatory Affairs |
| | Phone Number: | (914)-524-2431 |
| | Fax Number: | (914)-524-2101 |
| | E-mail Address: | Ernest.joseph@siemens.com |
| | Date Prepared: | May 21, 2014 |
-
- Device Name Proprietary Name: Measurand: Type of Test:
Regulation Section: Classification: Products Code:
- Device Name Proprietary Name: Measurand: Type of Test:
Panel:
-
- Predicate Device Name Predicate 510(k) No:
-
- Device Description:
-
- Intended Use: Indication for Use:
Special Conditions for Use Statement(s): Special Instrument Requirements:
IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) 21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Clinical Chemistry (75)
IMMULITE® 2000 PSA Calibration Verification Material
K131536
IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) contains one set of four vials (LPFCVM1-4), 2 mL each. LPFCVM1 contains bovine protein/buffer matrix with preservatives. LPFCVM2, LPFCVM3 and LPFCVM4 contain low, intermediate and high levels of Free PSA respectively, in human-source matrix with preservatives. The CVMs are supplied lyophilized form.
See Indications for Use Statement below The IMMULITE® Free PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen.
For prescription use only
IMMULITE® 2000 Systems
1
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 Free PSA CVM is substantially equivalent to the predicate device, IMMULITE® 2000 PSA CVM, as summarized in Table 1.
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| IMMULITE 2000 Free PSA | ||
| CVM | IMMULITE 2000 PSA CVM | |
| Intended Use | The IMMULITE® Free PSA | |
| Calibration Verification Material | ||
| (CVM) is intended for monitoring | ||
| system performance of the | ||
| IMMULITE Immunoassay system | ||
| for the quantitative measurement | ||
| of Free PSA antigen | The IMMULITE® 2000 PSA Calibration | |
| Verification Material (CVM) is intended | ||
| for monitoring system performance of the | ||
| IMMULITE Immunoassay system for the | ||
| quantitative measurement of PSA antigen | ||
| Levels | 4 | 4 |
| Stability | Stable unopened until the | |
| expiration date | Stable unopened until the | |
| expiration date | ||
| Storage | ≤-20°C | ≤-20°C |
| Use | Single Use Only | Single Use Only |
| Table 1: Substantial Equivalence Comparison | ||
|---|---|---|
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| IMMULITE 2000 Free PSA CVM | IMMULITE 2000 PSA CVM | |
| Analyte | Free PSA | PSA |
| Form | Lyophilized | Liquid |
| Matrix | Bovine Serum Albumin | Processed (pH-treated) Chicken Serum |
7. Non-Clinical Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the candidate device.
7.1 Stability Summary:
The stability study was conducted to validate the shelf life claim for the IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platform throughout the established shelf life of the CVM. The IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) stability study performed with CVM lot 15 shows acceptable results up to 3.5 years when stored at -20°C, and
2
SIEMENS
for on-going stability for lots 90 and 91 shows acceptable results up to 6 months at this time when stored at -20°C. Therefore the current shelf life stability claim is 6 months.
7.1.1 Stability Protocol Summary:
The CVMs are run as part of the calibrator stability testing. The stability calibrators/CVMs are run in duplicate (as a minimum) and the concentration value is determined from the reference internal calibration curve. Stability calibrators/CVMs are run at 6 months then annually up to the month after expiry. The stability will be tested at 24, 36 and 42 months.
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Free PSA Calibration Verification Material (CVM) requires that the dose concentration for the stability CVM is within 10% of assigned dose concentration.
| CVM Level | Assigned Dose (ng
free PSA/mL) | Acceptance Criteria
(% difference to
assigned dose) | Acceptable Range
(ng free PSA/mL) |
|-----------|------------------------------------|-----------------------------------------------------------|--------------------------------------|
| LPFCVM1 | 0.00 | N/A | N/A |
| LPFCVM2 | 0.20 | +10 | 0.18 - 0.22 |
| LPFCVM3 | 1.45 | +10 | 1.31 - 1.60 |
| LPFCVM4 | 24.40 | +10 | 21.96 - 26.84 |
Table 2: Stability Acceptance Criteria for IMMULITE 2000 Free PSA CVM
7.2 Traceability:
The IMMULITE Free PSA CVMs are traceable to WHO 15 NIBSC IS (96/668). The CVMs are manufactured using qualified materials and measurement procedures.
7.3 Value Assignment, Expected Values and Reference Range:
Free PSA CVMs are 4 level materials which are subset of 11 level Free PSA calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of Free PSA reagents and two point adjustors. The IMMULITE calibrators and therefore CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using Free PSA antigen stock and are traceable to internal material which has been gravimetrically prepared. Three levels of commercially available controls and 20 normal male patient samples, 10 spiked samples and 10 PSA patient samples were used to validate CVM value assignments.
The Free PSA CVM level were tested on 18 replicates in total comprised of 6 runs and 3 replicates per run on 4 IMMULITE 2000 system analyzers and 2 different reagent kit lots. The CVM values are calculated based on the recovered values for each run on each instrument independently. CVM values are then averages across all systems. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected assay range is 0.07 - 25.0 ng/mL. The controls must fall within their target ranges and the target specifications are shown in Table 4.
3
| Analyte
Target
Levels | Level | REF and
Lot number | Target Mean
(ng/mL) | SD | Guideline ± 2SD Range
(ng/mL) | |
|-----------------------------|-------|-----------------------|------------------------|--------|----------------------------------|-------|
| | CVM1 | LPFCVM1 015 | 0.00 | | 0.00 | 0.07 |
| | CVM2 | LPFCVM2 015 | 0.20 | 0.0125 | 0.17 | 0.22 |
| | CVM3 | LPFCVM3 015 | 1.45 | 0.08 | 1.29 | 1.61 |
| | CVM4 | LPFCVM4 015 | 24.40 | 1.2 | 22.0 | 26.8* |
| Assay Range | | 0.07 - 25.0 ng/mL | | | | |
Table 4: Analyte Target Range Levels
- The upper limit for this CVM exceeds the assay range of 25.0 ng/mL. The range of the CVM is determined from the precision %CV around the target. The upper limit of this CVM is within +10% of the assay range which ensures the whole of the assay range is covered.
Each laboratory should establish their limits for acceptability based on methodology, clinical significance and medical decision levels of the test analyte. The representative, total precision tabulated in the respective assay instructions for use may be considered as one factor when establishing local, acceptable ranges. The values provided above may be considered as guidelines. Value assignment is lot specific.
Standard/Guidance Documents Referenced:
- CEN 13640 Stability Testing of In Vitro Diagnostic Reagents .
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic ◆ Calibrators
- Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control � Material
Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10
8. Conclusion:
The IMMULITE® 2000 Free PSA 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, IMMULITE® 2000 PSA Calibration Verification Material. The substantial equivalence of the device is supported by the non-clinical testing and was found to be comparable and supports the claims of substantial equivalence, product safety and effectiveness. Based on the testing completed and the comparisons with predicate device, The IMMULITE® 2000 Free PSA Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the symbol. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gritt Silver Spring, MD 20993-0002
June 24, 2014
SIEMENS HEALTHCARE DIAGNOSTICS INC. MR. ERNEST JOSEPH SENIOR MANAGER, REGULATORY AFFAIRS 511 BENEDICT AVENUE TARRYTOWN. NY 10591
Re: K133816
Trade/Device Name: IMMULITE 2000 Free PSA Calibration Verification Material (CVM) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I Product Code: JJX Dated: June 16. 2016 Received: June 17, 2014
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 mav, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 Parts 801 and 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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 331-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Mr. Joseph
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 80) and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.fdaggov/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Elizabeth A. Stafford -S
for Maria M. Chan, Ph.D.
Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133816
Device Name
IMMULITE® 2000 Free PSA Calibration Verification Material
Indications for Use (Describe)
The IMMULITE® Free PSA Calibration Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth A. Stafford -S
FORM FDA 3881 (6/13)
PSC Publishing Services 13011 413-6740 EF