(75 days)
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No
The document describes a calibration verification material for an immunoassay system. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the chemical composition and analytical performance of the material.
No.
Explanation: The device is a "Calibration Verification Material" used for monitoring the performance of an immunoassay system, not for directly treating a medical condition.
No
The device is a Calibration Verification Material (CVM) intended for monitoring the performance of an immunoassay system, not for diagnosing patients. It is used to verify the accuracy of the system that measures PSA, not to directly measure or interpret patient PSA levels for diagnostic purposes.
No
The device description clearly states it contains physical vials of material (processed chicken serum matrix with and without PSA). This is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of PSA antigen." This indicates it is used in a laboratory setting to assess the performance of an in vitro diagnostic test (the PSA assay).
- Device Description: The description details the composition of the material, which is a processed serum matrix containing different levels of PSA. This material is designed to be run on an immunoassay system, which is an in vitro diagnostic instrument.
- Performance Studies: The document describes analytical performance studies, including traceability, stability, value assignment, and matrix effects. These are typical studies conducted for in vitro diagnostic devices to demonstrate their suitability for their intended use in a laboratory setting.
- Intended User: The intended user is "For prescription use only," which is common for IVD devices used in clinical laboratories.
- Predicate Device: The mention of a predicate device (Access Hybritech p2PSA QC) with a K number (K112603) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
While the device itself is a calibration verification material and not the primary diagnostic test for PSA, its function is to ensure the accuracy and reliability of an in vitro diagnostic test (the PSA assay). Therefore, it falls under the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Calibration Verification Material (CVM) contains one set of four vials, 3 mL each. LPTSCVM1 contains processed chicken serum matrix with preservative. LPTSCVM2, LPTSCVM3 and LPTSCVM4 contain low, intermediate and high levels of PSA respectively, in processed chicken serum/buffer matrix with preservative.
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
For prescription use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance:
- Traceability: The IMMULITE PSA Calibration Verification Materials are traceable to WHO 1st International Standard 96/670. The CVMs are manufactured using approved reference lot manufactured with qualified materials and measurement procedures. Gold Standards are anchored to WHO international standard NIBSC 96/670.
- Stability: The IMMULITE® 2000 Third Generation Calibration Verification Materials are stable up to 60 days when stored frozen at -20℃ prior to opening. Unopened stability is indicated by expiration date on the label when stored at -20°C.
- Value Assignment: The 8-level Calibrators are for internal use only and not available for commercial use. Calibrators are used during product release of PSA assay. Calibrators are manufactured and values ussigned using a stored curve generated with internal Gold Standards. The 4-level CVM module is a subset of calibrators intended for use by customers to monitor system performance. The PSA CVMs can be run periodically as unknowns in PSA assay by the customer to monitor system performance.
The IMMULITE Calibration Verification Materials (CVMs) are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using PSA antigen stock and are traceable to WHO 1st International Standard 96/670. The CVMs are manufactured using qualified materials and measurement procedures. The CVMs were tested on 27 replicates in total comprised of nine runs, six instruments and five different reagent kit lots. The CVMs dose values are generated using curve generated by assigned reference calibrators. The CVM values are calculated based on the recovered values for each run on each instrument independently. The CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples, spiked patient samples, normal male samples and controls using the assigned values. The controls must fall within their target ranges.
Production lots of CVMs are value assigned against the Gold Standard using two reagent kit lots and on a minimum of three different instruments. Quality control is performed by calculating the recovery of patient sample panels and controls using the assigned calibrator and CVM values. The calibrator values are calculated based on the recovered values for each run independently. Three levels of commercially available controls, 30 patient samples consisting of 10 normal male patient samples, 10 spiked human serum samples and 10 PSA samples were used to validate CVM value assignments. - Matrix Effects/Spiking Recovery: The spiking recovery of the IMMULITE® 2000 PSA Calibration Verification Material (CVM) was determined to investigate potential matrix effects from using processed (pHtreated) Chicken Serum. Siemens spiked three concentrations of purified PSA antigen into human serum and an evaluation lot comprised of chicken serum. The PSA values of the evaluation lot were compared to the human serum lots. The acceptance criteria were 100% ±15% with an overall average of ±10%. Each of the samples met the acceptance criteria, and Siemens concluded that there were no matrix effects.
Expected Values/Reference Range: Each CVM level was tested on 5 different kit lots, 6 instruments, 9 runs for a total of 27 replicates. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected values are provided in the IMMULITE® 2000 PSA Calibration verification Material lot-specific value sheet. The expected assay range is 0.08 - 150 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Access Hybritech p2PSA QC, K112603
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
SIEMENS
- 510(k) Summary as Required by 21 CFR 807.92
:
,7 ﺮ ﺳﺮ
Abbreviated 510(k) Premarket Notification IMMULITE® 2000 PSA Calibration Verification Material
| A. 510(k) Number: | New Device |
|---|---|
| B. Purpose for Submission: | Quality Control materials for the IMMULITE® 2000 PSA assay |
| C. Measurand: | |
| D. Type of Test: | Calibration Verification Material (CVM) for IMMULITE® 2000 PSA assay |
| E. Applicant: | |
| 1. Address: | Siemens Healthcare Diagnostics Inc. |
| 511 Benedict Avenue | |
| Tarrytown, NY 10591 | |
| AUG 1 2 2013 | |
| 2. Contact Person: | Garo Mimaryan, MS., RAC |
| Technical Regulatory Affairs Specialist III | |
| 3. Phone Number: | (914)-524-3270 |
| F. Proprietary and | |
| Established Names: | IMMULITE® 2000 PSA Calibration Verification Material |
| G. Regulatory Information: | |
| 1. Regulation Section: | 21 CFR 862.1660, Quality Control Material |
| 2. Classification: | Class I Reserved |
| 3. Products Codes: | JJX – Single (Specified) Analyte Controls (Assayed and Unassayed) |
| 4. Panel: | Clinical Chemistry (75) |
| H. Intended Use: | |
| 1. Intended Use(s): | See Indications for Use below. |
| 2. Indications for Use: | 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. | |
| 3. Special Conditions for | |
| Use Statement(s). | For prescription use only. |
| 4. Special Instrument | |
| Requirements: | IMMULITE® 2000 Systems |
| I. Device Description: | The Calibration Verification Material (CVM) contains one set |
| of four vials, 3 mL each. LPTSCVM1 contains processed | |
| chicken serum matrix with preservative. LPTSCVM2, | |
| LPTSCVM3 and LPTSCVM4 contain low, intermediate and | |
| high levels of PSA respectively, in processed chicken | |
| serum/buffer matrix with preservative. |
1
Image /page/1/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The font is bold and black, contrasting with the white background. The letters are evenly spaced and appear to be sans-serif. The image is clear and easy to read.
J. Substantial Equivalence
- . Information:
- Access Hybritech p2PSA QC 1. Predicate Device Name:
-
- Predicate 510(k) No. K112603
-
- Comparison with Predicate:
- A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 PSA Calibration Verification Material (CVM) is substantially equivalent to the predicate device, Access Hybritech p2PSA QC, as summarized in the following table.
| REAGENT SIMILARITIES and DIFFERENCES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| IMMULITE 2000 PSA CVM | Access Hybritech p2PSA QC | |
| Intended Use | 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. | The Access Hybritech PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]pro PSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. |
| Analyte | PSA | [-2]proPSA isoform of Prostate Specific Antigen (PSA) |
| Form | Liquid | Same |
| Stability | Stable until the expiration date when stored frozen. | Same |
| Storage | -20°C | -20°C |
| Matrix | Processed (pH-treated) Chicken Serum | Bovine Serum Albumin and buffering salts |
| Use | Single Use Only | Not for Single Use |
K. 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
L. Test Principle:
Not Applicable
2
M. Performance Characteristics
-
- Analytical Performance:
- a. Precision/Reproducibility: Not Applicable
- b. Linearity/assay Reportable Range: Not Applicable
- c. Traceability, Stability, Expected Values (controls, calibrators, methods):
Traceability:
The IMMULITE PSA Calibration Verification Materials are traceable to WHO 1st International Standard 96/670.The CVMs are manufactured using approved reference lot manufactured with qualified materials and measurement procedures.
Stability:
The IMMULITE® 2000 Third Generation Calibration Verification Materials are stable up to 60 days when stored frozen at -20℃ prior to opening. Unopened stability is indicated by expiration date on the label when stored at -20°C.
Value Assignment:
The 8-level Calibrators are for internal use only and not available for commercial use. Calibrators are used during product release of PSA assay. Calibrators are manufactured and values ussigned using a stored curve generated with internal Gold Standards. Gold Standards are anchored to WHO international standard NIBSC 96/670. The 4-level CVM module is a subset of calibrators intended for use by customers to monitor system performance. The PSA CVMs can be run periodically as unknowns in PSA assay by the customer to monitor system performance.
The IMMULITE Calibration Verification Materials (CVMs) are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using PSA antigen stock and are traceable to WHO 1st International Standard 96/670. The CVMs are manufactured using qualified materials and measurement procedures. The CVMs were tested on 27 replicates in total comprised of nine runs, six instruments and five different reagent kit lots. The CVMs dose values are generated using curve generated by assigned reference calibrators. The CVM values are calculated based on the recovered values for each run on each instrument independently. The CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples, spiked patient samples, normal male samples and controls using the assigned values. The controls must fall within their target ranges.
Production lots of CVMs are value assigned against the Gold Standard using two reagent kit lots and on a minimum of three different instruments. Quality control is performed by calculating the recovery of patient sample panels and controls using the assigned calibrator and CVM values. The calibrator values are calculated based on the recovered values for each run independently. Three levels of commercially available controls, 30 patient samples consisting of 10 normal male patient samples, 10 spiked human serum samples and 10 PSA samples were used to validate CVM value assignments.
3
The spiking recovery of the IMMULITE® 2000 PSA Calibration Verification Material (CVM) was determined to investigate potential matrix effects from using processed (pHtreated) Chicken Serum. Siemens spiked three concentrations of purified PSA antigen into human serum and an evaluation lot comprised of chicken serum. The PSA values of the evaluation lot were compared to the human serum lots. The acceptance criteria were 100% ±15% with an overall average of ±10%. Each of the samples met the acceptance criteria, and Siemens concluded that there were no matrix effects.
- Detection limit: Not Applicable d.
- Analytical Specificity: Not Applicable e.
- Assay cut-off: Not Applicable f.
-
- Comparison Studies
- a. Method Comparison with predicate device: Not Applicable
- b. Matrix Comparison: Not Applicable
-
- Clinical Studies:
- a. Clinical Sensitivity and Specificity: Not Applicable
- b. Other clinical supportive data (when a. and b. are not applicable): Not Applicable
- Clinical Cut-off: Not Applicable 4.
5. Expected Values/Reference Range:
Each CVM level was tested on 5 different kit lots, 6 instruments, 9 runs for a total of 27 replicates. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected values are provided in the IMMULITE® 2000 PSA Calibration verification Material lot-specific value sheet. The expected assay range is 0.08 - 150 ng/mL. The values below can be considered as guidelines.
| Analyte
target | Level | Target Mean
(ng/mL) | SD | Guideline
(ng/mL)