(28 days)
Not Found
No
The document describes calibration verification materials for laboratory assays and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic use, specifically for the verification of calibration of assays on IMMULITE 2000 systems. It is not used to treat, diagnose, or mitigate disease in a patient, which are characteristics of a therapeutic device.
No
This device is described as "Calibration Material" and "for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide/SHBG/Total Testosterone assay on the IMMULITE 2000 systems." It is used to verify the calibration of a diagnostic assay, not to diagnose a condition itself.
No
The device description clearly states that the device is a physical material (lyophilized or liquid) contained in vials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The IMMULITE® C-Peptide Calibration Material (CVM) is for in vitro diagnostic use..."
- "The IMMULITE® SHBG Calibration Material (CVM) is for in vitro diagnostic use..."
- "The IMMULITE® Total Testosterone Calibration Material (CVM) is for in vitro diagnostic use..."
This statement directly indicates that the device is intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The device is used to verify the calibration of assays that measure substances in biological samples (C-Peptide, SHBG, Total Testosterone), which are typical in vitro diagnostic procedures.
N/A
Intended Use / Indications for Use
The IMMULITE® C-Peptide Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide assay on the IMMULITE 2000 systems.
The IMMULITE® SHBG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE SHBG assay on the IMMULITE 2000 systems.
The IMMULITE® Total Testosterone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total Testosterone assay on the IMMULITE 2000 systems.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
IMMULITE® 2000 C-Peptide Calibration Verification Material:
The C-Peptide Calibration Verification Material (CVM) contains one set of four vials each 2mL. CVM1 contains a lyophilized buffered human albumin with bovine protein. 0.197% sodium azide and preservative CVM2, CVM3 and CVM4 contain various levels of lyophilized C-Peptide in buffered human albumin with bovine protein, 0.197% sodium azide and preservative. CVMs are supplied frozen in a lyophilized form.
IMMULITE® 2000 SHBG Calibration Verification Material:
IMMULITE® 2000 SHBG Calibration Verification Material (CVM) contains one set of four vials, 2mL (CVM1) and 2 mL (CVM2, CVM3 and CVM4) each. CVM1 contains a lyophilized buffered bovine protein/buffer matrix with 3.64% sodium azide and preservative. CVM2, CVM3, and CVM4 contain various levels of lyophilized SHBG in bovine protein/buffer matrix with 3.64% sodium azide and preservative CVMs are supplied frozen in lyophilized form.
IMMULITE® 2000 Total Testosterone Calibration Verification Material:
IMMULITE® 2000 Total Testosterone Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM1 contains processed human serum with 0.98% sodium azide and other preservative. CVM2, CVM3, and CVM4 contain various levels of testosterone in processed human serum with 0.98% sodium azide and other preservative. The CVMs are supplied frozen in a liquid form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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)
IMMULITE® 2000 C-Peptide Calibration Verification Material:
- Stability Summary: The stability study was conducted to validate shelf life claim for the IMMULITE 2000 C-Peptide Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM. The Calibration Verification Materials are stable up to 6 years when stored at 2-8°C prior to opening and stable for 8 hours at room (ambient) temperature (15-25°C) after reconstitution.
- Shelf life Stability Protocol Summary: The CVM study protocols are run as part of the calibrator stability testing. The testing was run in duplicate (at the minimum) and contains time-points at which the testing was performed (1, 1642, 1825, 2190 days for all CVM levels).
- Shelf life Stability Acceptance Criteria Summary: Dose value of stability CVM to fall between ±15% of assigned dose for CVM levels 2 and 4 and ±10% of assigned dose for CVM level 3. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range then an additional data review is conducted using part 2 criteria.
- Open Vial Stability Protocol Summary: The C-Peptide CVMs were tested at 2-hourly intervals for up to 9 hours at room temperature (ambient) conditions (0, 2, 4, 8 hours for all CVM levels).
- Open Vial Stability Acceptance Criteria Summary: The Acceptance Criteria for the Open Vial Stability are the Shelf life Stability Acceptance criteria.
- Value Assignment: The IMMULITE C-Peptide CVMs are 4 level materials which are a subset of 10 level Total C-Peptide calibrators. CVMs are value assigned using assigned reference calibrators. 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 and then averaged across all systems. Quality control is performed by calculating the recovery of patient samples, spiked patient samples and controls using the assigned CVM values, which must fall within their target ranges. Six levels of commercially available controls and 59 normal patient samples were used to validate CVM value assignments.
IMMULITE® 2000 SHBG Calibration Verification Material:
- Stability Summary: The stability study was conducted to validate shelf life claim for the IMMULITE 2000 SHBG Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM. The Calibration Verification Materials are stable up to 9 years when stored at 2-8°C prior to opening and stable for 8 hours at room (ambient) temperature (15-25°C) after reconstitution.
- Shelf Life Stability Protocol Summary: The CVM study protocols are run as part of the calibrator stability testing. The testing was run in duplicate (at the minimum) and contains time-points at which the testing was performed (1, 2190, 2555, 3285 days for all CVM levels).
- Shelf Life Stability Acceptance Criteria Summary: Dose value of stability CVM to fall between ±10% of assigned dose for CVM levels 2 & 3 and ±20% of assigned dose for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range then additional data review is conducted using part 2 criteria.
- Open Vial Stability Protocol Summary: SHBG CVMs were tested at 2-hourly intervals for up to 9 hours at room temperature (ambient) conditions (0, 2, 4, 8 hours for all CVM levels).
- Open Vial Stability Acceptance Criteria Summary: The Acceptance Criteria for the Open Vial Stability are the Shelf life Stability Acceptance criteria.
- Value Assignment: The IMMULITE SHBG CVMs are 4 level materials which are a subset of 9 level SHBG calibrators. CVMs are value assigned using assigned reference calibrators. 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 and then averaged across all systems. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values, which must fall within their target ranges. Four levels of commercially available controls and 28 normal patient samples were used to validate CVM value assignments.
IMMULITE® 2000 Total Testosterone Calibration Verification Material:
- Stability Summary: The stability study was conducted to validate shelf life claim for the IMMULITE 2000 Total Testosterone CVM to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM. The Calibration Verification Materials are stable up to 26 months when stored at -20°C prior to opening and stable for 6 hours at room (ambient) temperature (15-25°C).
- Shelf Life Stability Protocol Summary: The CVM study protocols are run as part of the calibrator stability testing. The testing was run in duplicate (at the minimum) and contains time-points at which the testing was performed (1, 182, 365, 790 days for all CVM levels).
- Shelf Life Stability Acceptance Criteria Summary: Dose value of stability CVM to fall between ±15% of assigned dose for CVM level 2, ±10% of assigned dose for CVM level 3 and ±9% of assigned dose for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range then additional data review is conducted using part 2 criteria.
- Open Vial Stability Protocol Summary: The Total Testosterone CVMs were tested at 2-hourly intervals for up to 9 hours at room temperature (ambient) conditions (0, 2, 4, 8 hours for all CVM levels).
- Open Vial Stability Acceptance Criteria Summary: The Acceptance Criteria for the Open Vial Stability are the Shelf life Stability Acceptance criteria.
- Value Assignment: The IMMULITE® 2000 Total Testosterone CVMs are 4 level materials which are a subset of 9 level Total Testosterone calibrators. CVMs are value assigned using assigned reference calibrators. 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 and then averaged across all systems. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values. Six levels of commercially available controls and 32 samples (23 spiked samples, 4 normal female and 5 normal male samples) were used to validate CVM value assignments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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
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: K140541
- Submitter Mailing Address: Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 Contact Person:
Phone Number: Fax Number: E-mail Address: Date Prepared:
-
- 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:
- Predicate Device Name
-
- Device Description:
-
- Intended Use: Indication for Use:
Special Conditions for Use Statement(s): Special Instrument Requirements:
Garo Mimaryan, MS, RAC Senior Regulatory Affairs Specialist (914)-524-3270 (914)-524-2101 garo.mimaryan@siemens.com March 27. 2014
IMMULITE® 2000 C-Peptide Calibration Verification Material Quality Control materials for IMMULITE® 2000 C-Peptide assay Calibration Verification Material (CVM) for IMMULITE® 2000 C-Peptide assay 21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassaved) Clinical Chemistry (75)
IMMULITE® 2000 Growth Hormone Calibration Verification Material (CVM) K133128
The C-Peptide Calibration Verification Material (CVM) contains one set of four vials each 2mL. CVM1 contains a lyophilized buffered human albumin with bovine protein. 0.197% sodium azide and preservative CVM2, CVM3 and CVM4 contain various levels of lyophilized C-Peptide in buffered human albumin with bovine protein, 0.197% sodium azide and preservative. CVMs are supplied frozen in a lyophilized form
See Indications for Use Statement below The IMMULITE® C-Peptide Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide assay on the IMMULITE 2000 systems
For prescription use only IMMULITE® 2000 Systems
1
6. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 C-Peptide Calibration Verification Material (CVM) is substantially equivalent to the predicate device as summarized in Table 1.
Table 1: Substantial Equivalence Comparison
| SIMILARITIES | |||
|---|---|---|---|
| Candidate Device | |||
| IMMULITE 2000 C-Peptide CVM | Predicate Device | ||
| IMMULITE 2000 Growth Hormone | |||
| CVM | |||
| Intended | |||
| Use | The IMMULITE® C-Peptide | ||
| Calibration Verification Material | |||
| (CVM) is for in vitro diagnostic use in | |||
| the verification of calibration of the | |||
| IMMULITE C-Peptide assay on the | |||
| IMMULITE 2000 systems. | The IMMULITE® Growth Hormone | ||
| Calibration Verification Material | |||
| (CVM) is for in vitro diagnostic use in | |||
| the verification of calibration of the | |||
| IMMULITE Growth Hormone assay | |||
| on the IMMULITE 2000 systems | |||
| Form | Lyophilized | Same | |
| Storage | 2-8°C | Same | |
| Stability | Stable unopened until the | ||
| expiration date | Same | ||
| Levels | 4 | Same | |
| Use | Single Use Only | Same | |
| DIFFERENCES | |||
| Candidate Device | |||
| IMMULITE 2000 C-Peptide CVM | Predicate Device | ||
| IMMULITE 2000 Growth Hormone | |||
| CVM | |||
| Analyte | C-Peptide | Growth Hormone | |
| Matrix | Human Albumin* with preservatives | Equine Serum with preservatives |
*This material was tested negative for HIV-1, HIV-2 and hepatitis by FDA approved methods.
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.
Stability Summary:
The stability study was conducted to validate shelf life claim for the IMMULITE 2000 C-Peptide Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM. The Calibration Verification Materials are stable up to 6 years when stored at 2-8°C prior to opening and stable for 8 hours at room (ambient) temperature (15-25°C) after reconstitution.
2
Shelf life Stability Protocol Summary:
The CVM study protocols are run as part of the calibrator stability testing. As summarized in Table 2, the testing was run in duplicate (at the minimum) and contains time-points at which the testing was performed.
Table 2: Shelf life Stability Protocol Summary
| CVM Level | Time-Points
(Days) | | | |
|-----------|-----------------------|------|------|------|
| LPEPCVM1 | 1 | 1642 | 1825 | 2190 |
| LPEPCVM2 | 1 | 1642 | 1825 | 2190 |
| LPEPCVM3 | 1 | 1642 | 1825 | 2190 |
| LPEPCVM4 | 1 | 1642 | 1825 | 2190 |
Shelf life Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE C-Peptide criteria which require dose value of stability CVM to fall between ±15% of assigned dose for CVM levels 2 and 4 and ±10% of assigned dose for CVM level 3. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range of ±15% for levels 2 and 4 and ±10% for level 3 then an additional data review is conducted using part 2 criteria
Open Vial Stability Protocol Summary:
As summarized in Table 3, The C-Peptide CVMs were tested at 2-hourly intervals for up to 9 hours at room temperature (ambient) conditions.
Table 3: Open Vial Stability Protocol Summary
| CVM Level | Time-Points
(Hours) | | | |
|-----------|------------------------|---|---|---|
| LPEPCVM1 | 0 | 2 | 4 | 8 |
| LPEPCVM2 | 0 | 2 | 4 | 8 |
| LPEPCVM3 | 0 | 2 | 4 | 8 |
| LPEPCVM4 | 0 | 2 | 4 | 8 |
Open Vial Stability Acceptance Criteria Summary:
The Acceptance Criteria for the Open Vial Stability are the Shelf life Stability Acceptance criteria.
Traceability:
The IMMULITE C-Peptide CVMs are traceable to WHO 1st IRP 84/510. The CVMs are manufactured using qualified materials and measurement procedures.
3
Value Assignment:
The IMMULITE C-Peptide CVMs are 4 level materials which are a subset of 10 level Total C-Peptide calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of C-Peptide reagents and two point adjustors. The IMMULITE calibrators and therefore CVMs are value assigned using assigned reference calibrators. The CVMs are manufactured using qualified materials and measurement procedures. 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. CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples, spiked patient samples and controls using the assigned CVM values. The controls must fall within their target ranges. Six levels of commercially available controls and 59 normal patient samples were used to validate CVM value assignments.
Expected Values/Target Values/Reference Range:
Each CVM level was tested for a total of 27 replicates; 9 runs and 3 replicates per run, 5 different reagent kit lots and 9 IMMULITE 2000 systems. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The target values are provided in the IMMULITE® 2000 CVM Calibration verification Material lotspecific value card. The expected assay range is 0.1 - 20 ng/mL. The target values in Table 4 can be considered as guidelines.
| Analyte target
levels | CVM Level | Target
Mean
(ng/mL) | Standard
Deviation
(SD) | Target Range
(ng/mL) | |
|--------------------------|------------------------------------|---------------------------|-------------------------------|-------------------------|-------|
| | LPEPCVM1 | 0.00 | - | ≤0.1 | |
| | LPEPCVM2 | 0.520 | 0.039 | 0.442 | 0.598 |
| | LPEPCVM3 | 8.85 | 0.4425 | 7.97 | 9.74 |
| | LPEPCVM4 | 25.6 | - | - | |
| | ( 80% LPEPCVM4 +
20% LPEPCVM1 ) | 20.5 | 1.55 | 17.4 | 23.6 |
| Assay Range | 0.1-20 ng/mL | | | | |
Table 4: Analyte Target Range Values
Assay Range | 0.1 - 20 ng/mL
*Note: LPEPCVM4 requires dilution to ensure the target value is within +10% of the top of the reportable range of the assay.
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
4
9. Conclusion:
The IMMULITE® 2000 C-Peptide Calibration Verification Material is substantially equivalent to the predicate device intended for similar use. 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 C-Peptide Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
5
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: K140541
-
- Submitter
Mailing Address:
- Submitter
Contact Person:
Phone Number: Fax Number: E-mail Address: Date Prepared:
-
- 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:
4. Device Description:
-
- Intended Use: Indication for Use:
Special Conditions for Use Statement(s): Special Instrument Requirements:
- Intended Use: Indication for Use:
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591
Garo Mimaryan, MS, RAC Senior Regulatory Affairs Specialist (914)-524-3270 (914)-524-2101 garo.mimaryan@siemens.com March 27, 2014
IMMULITE® 2000 SHBG Calibration Verification Material Quality Control materials for IMMULITE® 2000 SHBG assay Calibration Verification Material (CVM) for IMMULITE® 2000 SHBG assav 21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Clinical Chemistry (75)
IMMULITE 2000 Growth Hormone CVM K133128
IMMULITE® 2000 SHBG Calibration Verification Material (CVM) contains one set of four vials, 2mL (CVM1) and 2 mL (CVM2, CVM3 and CVM4) each. CVM1 contains a lyophilized buffered bovine protein/buffer matrix with 3.64% sodium azide and preservative. CVM2, CVM3, and CVM4 contain various levels of lyophilized SHBG in bovine protein/buffer matrix with 3.64% sodium azide and preservative CVMs are supplied frozen in lyophilized form.
See Indications for Use Statement below
The IMMULITE® SHBG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE SHBG assay on the IMMULITE 2000 systems
For prescription use only IMMULITE® 2000 Systems
6
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 SHBG Calibration Verification Material (CVM) is substantially equivalent to the predicate device as summarized in Table 1.
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 SHBG CVM | Predicate Device | |
| IMMULITE 2000 Growth Hormone | ||
| CVM | ||
| Intended | ||
| Use | The IMMULITE® SHBG | |
| Calibration Verification Material | ||
| (CVM) is for in vitro diagnostic use | ||
| in the verification of calibration of | ||
| the IMMULITE SHBG assay on the | ||
| IMMULITE 2000 systems | The IMMULITE® Growth Hormone | |
| Calibration Verification Material (CVM) | ||
| is for in vitro diagnostic use in the | ||
| verification of calibration of the | ||
| IMMULITE Growth Hormone assay on | ||
| the IMMULITE 2000 systems | ||
| Form | Lyophilized | Same |
| Storage | 2-8°C | Same |
| Stability | Stable unopened until the | |
| expiration date | Same | |
| Levels | 4 | Same |
| Use | Single Use Only | Same |
| Table 1: Substantial Equivalence Comparison | |||
|---|---|---|---|
| -- | -- | --------------------------------------------- | -- |
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 SHBG CVM | Predicate Device | |
| IMMULITE 2000 Growth Hormone | ||
| CVM | ||
| Analyte | SHBG | Growth Hormone |
| Matrix | Buffered bovine/protein with | |
| preservatives | Equine Serum with preservatives |
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.
Stability Summary:
The stability study was conducted to validate shelf life claim for the IMMULITE 2000 SHBG Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM. The Calibration Verification Materials are stable up to 9 years when stored at 2-8°C prior to opening and stable for 8 hours at room (ambient) temperature (15-25°C) after reconstitution.
Shelf Life Stability Protocol Summary:
The CVM study protocols are run as part of the calibrator stability testing. As summarized in Table 2, the testing was run in duplicate (at the minimum) and contains time-points at which the testing was performed.
7
| CVM Level | Time-Points
(Days) | | | |
|-----------|-----------------------|------|------|------|
| LSHCVM1 | 1 | 2190 | 2555 | 3285 |
| LSHCVM2 | 1 | 2190 | 2555 | 3285 |
| LSHCVM3 | 1 | 2190 | 2555 | 3285 |
| LSHCVM4 | 1 | 2190 | 2555 | 3285 |
Table 2: Shelf Life Stability Protocol Summary
Shelf Life Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE SHBG Calibration Material (CVM) are in 2 parts. Part 1 consists of the guideline acceptance criteria which require dose value of stability CVM to fall between ±10% of assigned dose for CVM levels 2 & 3 and ±20% of assigned dose for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range of ±10% for levels 2 & 3 and ±20% for level 4 then additional data review is conducted using part 2 criteria.
Open Vial Stability Protocol Summary:
As summarized in Table 3, SHBG CVMs were tested at 2-hourly intervals for up to 9 hours at room temperature (ambient) conditions.
Table 3: Open Vial Stability Protocol Summary
| CVM Level | Time-Points
(Hours) | | | |
|-----------|------------------------|---|---|---|
| LSHCVM1 | 0 | 2 | 4 | 8 |
| LSHCVM2 | 0 | 2 | 4 | 8 |
| LSHCVM3 | 0 | 2 | 4 | 8 |
| LSHCVM4 | 0 | 2 | 4 | 8 |
Open Vial Stability Acceptance Criteria Summary:
The Acceptance Criteria for the Open Vial Stability are the Shelf life Stability Acceptance criteria.
Traceability:
The IMMULITE SHBG CVMs are traceable to an internal material which has been gravimetrically prepared. The CVMs are manufactured using qualified materials and measurement procedures,
8
Value Assignment:
The IMMULITE SHBG CVMs are 4 level materials which are a subset of 9 level SHBG calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of SHBG reagents and two point adjustors. The IMMULITE calibrators and therefore CVMs are value assigned using assigned reference calibrators. 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 and controls using the assigned CVM values. The controls must fall within their target ranges. Four levels of commercially available controls and 28 normal patient samples were used to validate CVM value assignments. Quality control is performed by calculating the recovery of patient samples, spiked patient samples and controls using the assigned CVM values. The controls must fall within their target ranges
Expected Values/Target Values/Reference Range:
The CVMs are manufactured using qualified materials and measurement procedures. The SHBG CVMs were tested on 27 replicates in total comprised of 9 runs and 3 replicates per run on 8 IMMULITE 2000 systems and 1 reagent kit lot. 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 and controls using the assigned CVM values. 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 2-180 nmol/L. The target values in Table 4 can be considered as guidelines.
| Analyte target
levels | CVM Level | Target
Mean
(nmol/L) | Standard
Deviation
(SD) | Target Range
(nmol/L) | |
|--------------------------|--------------------------------|----------------------------|-------------------------------|--------------------------|------|
| | LSHCVM1 | 0.00 | - | 0.00 | ≤2.0 |
| | LSHCVM2 | 6.00 | 0.3 | 5.40 | 6.60 |
| | LSHCVM3 | 47.2 | 2.6 | 42 | 52.4 |
| | *LSHCVM4 | 216 | - | - | - |
| | (85% LSHCVM4 +
15% LSHCVM1) | 184 | 18.5 | 147 | 221 |
| Assay Range | 2 - 180 nmol/L | | | | |
Table 4: Analyte Target Range Levels
*Note: LSHCVM4 requires dilution to ensure the target value is within +10% of the reportable range of the assay.
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 .
9
Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10
9. Conclusion:
The IMMULITE® 2000 SHBG Calibration Verification Material is substantially equivalent to the predicate device intended for similar use. 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 SHBG Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
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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: K140541
Special Conditions for
Use Statement(s): Special Instrument
Requirements:
| Submitter | Siemens Healthcare Diagnostics Inc. |
|---|---|
| Mailing Address: | 511 Benedict Avenue |
| Tarrytown, NY 10591 | |
| Contact Person: | Garo Mimaryan, MS, RAC |
| Senior Regulatory Affairs Specialist | |
| Phone Number: | (914)-524-3270 |
| Fax Number: | (914)-524-2101 |
| E-mail Address: | garo.mimaryan@siemens.com |
| Date Prepared: | March 27, 2014 |
| 2. Device Name | IMMULITE® 2000 Total Testosterone Calibration Verification Material |
| Proprietary Name: | Quality Control materials for IMMULITE 2000 Total Testosterone |
| Measurand: | Calibration Verification Material (CVM) for IMMULITE® 2000 |
| Type of Test: | Total Testosterone assay |
| Regulation Section: | 21 CFR 862.1660, Quality Control Material |
| Classification: | Class I Reserved |
| Products Code: | JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device Name | IMMULITE® 2000 HCG Calibration Verification Material |
| Predicate 510(k) No: | K133128 |
| 4. Device Description: | IMMULITE® 2000 Total Testosterone Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM1 contains processed human serum with 0.98% sodium azide and other preservative. CVM2, CVM3, and CVM4 contain various levels of testosterone in processed human serum with 0.98% sodium azide and other preservative. The CVMs are supplied frozen in a liquid form. |
| 5. Intended Use: | |
| Indication for Use: | See Indications for Use Statement below |
The IMMULITE® Total Testosterone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of the IMMULITE Total Testosterone assay on the IMMULITE 2000 systems
For prescription use only IMMULITE® 2000 Systems
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6. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 Total Testosterone Calibration Verification Material (CVM) is substantially equivalent to the predicate device, as summarized in Table 1.
| Table 1: Substantial Equivalence Comparison | ||
|---|---|---|
| SIMILARITIES | |||
|---|---|---|---|
| Candidate Device | |||
| IMMULITE 2000 Total Testosterone | |||
| CVM | Predicate Device | ||
| IMMULITE 2000 HCG CVM | |||
| Intended | |||
| Use | The IMMULITE® Total Testosterone | ||
| Calibration Verification Material (CVM) | |||
| is for in vitro diagnostic use in the | |||
| verification of calibration of the | |||
| IMMULITE Total Testosterone assay on | |||
| the IMMULITE 2000 systems | The IMMULITE® HCG Calibration | ||
| Verification Material (CVM) is for in | |||
| vitro diagnostic use in the verification | |||
| of calibration of the IMMULITE | |||
| HCG assay on the IMMULITE 2000 | |||
| systems | |||
| Form | Liquid | Same | |
| Levels | 4 | Same | |
| Matrix | Human Serum* with preservatives | Same | |
| Stability | Stable unopened until the expiration date | Same | |
| Storage | ≤20°C | Same | |
| Use | Single Use Only | Same | |
| DIFFERENCES | |||
| DIFFERENCES | |||
| Candidate Device | |||
| IMMULITE 2000 Total Testosterone | |||
| CVM | Predicate Device | ||
| IMMULITE 2000 HCG CVM | |||
| Analyte | Testosterone | HCG |
- This material was tested negative for HIV-1, HIV-2 and hepatitis by FDA approved methods,
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.
Stability Summary:
The stability study was conducted to validate shelf life claim for the IMMULITE 2000 Total Testosterone CVM to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM. The Calibration Verification Materials are stable up to 26 months when stored at -20°C prior to opening and stable for 6 hours at room (ambient) temperature (15-25°C).
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Shelf Life Stability Protocol Summary:
The CVM study protocols are run as part of the calibrator stability testing. As summarized in Table 2, the testing was run in duplicate (at the minimum) and contains time-points at which the testing was performed.
Table 2: Shelf Life Stability Protocol Summary
| CVM Level | Time-Points
(Days) | | | |
|-----------|-----------------------|-----|-----|-----|
| LTWCVMI | 1 | 182 | 365 | 790 |
| LTWCVM2 | 1 | 182 | 365 | 790 |
| LTWCVM3 | 1 | 182 | 365 | 790 |
| LTWCVM4 | 1 | 182 | 365 | 790 |
Shelf Life Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Total Testosterone criteria which require dose value of stability CVM to fall between ±15% of assigned dose for CVM level 2, ±10% of assigned dose for CVM level 3 and ±9% of assigned dose for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range of ±15% for level 2, ±10% for level 3 and ±9% for level 4 then additional data review is conducted using part 2 criteria.
Open Vial Stability Protocol Summary:
As summarized in Table 3, The Total Testosterone CVMs were tested at 2-hourly intervals for up to 9 hours at room temperature (ambient) conditions.
| CVM Level | Time-Points
(Hours) | | | |
|-----------|------------------------|---|---|---|
| LTWCVMI | 0 | 2 | 4 | 8 |
| LTWCVM2 | 0 | 2 | 4 | 8 |
| LTWCVM3 | 0 | 2 | 4 | 8 |
| LTWCVM4 | 0 | 2 | 4 | 8 |
Table 3: Open Vial Stability Protocol Summary
Open Vial Stability Acceptance Criteria Summary:
The Acceptance Criteria for the Open Vial Stability are the Shelf life Stability Acceptance criteria.
Traceability:
The IMMULITE Total Testosterone CVMs are traceable to an internal material which has been gravimetrically prepared. The CVMs are manufactured using qualified materials and measurement procedures.
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Value Assignment:
The IMMULITE® 2000 Total Testosterone CVMs are 4 level materials which are a subset of 9 level Total Testosterone calibrators are not commercialized but are used internally during manufacture and release testing of Total Testosterone reagents and two point adjustors. The IMMULITE calibrators and therefore CVMs are value assigned using assigned reference calibrators. 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. CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values. Six levels of commercially available controls and 32 samples (23 spiked samples, 4 normal female and 5 normal male samples) were used to validate CVM value assignments. Quality control is performed by calculating the recovery of patient samples, spiked patient samples and controls using the assigned CVM values. The controls must fall within their target ranges
Expected Values/Target Values/Reference Range:
The Total Testosterone CVMs were tested on 27 replicates in total comprised of 9 runs and 3 replicates per run, 9 IMMULITE 2000 systems and 5 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 instrument independently. CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values. 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 20-1600 ng/dL. The target values in Table 4 can be considered as guidelines.
| Analyte target
levels | Level | Target
Mean
(ng/dL) | Standard
Deviation
(SD) | Target Range
(ng/dL) |
|--------------------------|--------------------------------|---------------------------|-------------------------------|-------------------------|
| | LTWCVMI | 0.00 | - | 0.00 $≤$ 0.20 |
| | LTWCVM2 | 73.5 | 13.675 | 46.3 101 |
| | LTWCVM3 | 405 | 36.5 | 332 478 |
| | *LTWCVM4 | 2016 | - | - |
| | (80% LTWCVM4 +
20% LTWCVMI) | 1613 | 121 | 1371 1855 |
| Assay Range | 20 - 1600 ng/dL | | | |
Table 4: Analyte Target Range Levels
*Note: LTWCVM4 requires dilution to ensure the target value is within +10% of the top of the reportable range of
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 .
14
Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10
9. Conclusion:
The IMMULITE® 2000 Total Testosterone Calibration Material is substantially equivalent to the predicate device intended for similar use. 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 Total Testosterone Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
15
Image /page/15/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling three abstract shapes that are stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2014
SIEMENS HEALTHCARE DIAGNOSTICS INC. GARO MIMARYAN SENIOR REG. AFFAIRS SPECIALIST 511 BENEDICT AVE. TARRYTOWN NY 10591
Rc: K140541
Trade/Device Name: IMMULITE® 2000 C-Peptide Calibration Verification Material, IMMULITE® 2000 SHBG Calibration Verification Material. IMMULITE® 2000 Total Testosterone Calibration Verification Matcrial Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX
Dated: February 28, 2014 Received: March 4, 2014
Dear Garo Mimaryan:
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. 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 cither 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 of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the
16
Page 2-Garo Mimaryan
clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safety/Reportal?roblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
17
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) k 140541
Device Name
IMMULITE®2000 C-Peptide Calibration Material, IMMULITE®2000 SHBG Calibration Verification Material, and IMMULITE®2000 Total Testosterone Calibration Verification Material
Indications for Use (Describe)
The IMMULITE® C-Peptide Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide assay on the IMMULITE 2000 systems.
The IMMULITE® SHBG Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE SHBG assay on the IMMULITE 2000 systems.
The IMMULITE® Total Testosterone Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total Testosterone assay on the IMMULITE 2000 systems.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 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)
Yung W. Chan -S
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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