(22 days)
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No
The document describes calibration verification materials, which are reagents used to check the performance of an assay on a specific instrument. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on traditional analytical validation methods like stability, traceability, and value assignment.
No
Explanation: The device is described as a 'Calibration Verification Material' intended for 'in vitro diagnostic use in the verification of calibration' of assays. Its purpose is to ensure the accuracy of diagnostic tests, not to treat or directly manage a patient's health condition.
No
The device is described as "Calibration Verification Material (CVM)", which is used for the verification of calibration of an assay, not for direct diagnosis. While it's "for in vitro diagnostic use", it serves to ensure the accuracy of diagnostic assays rather than being a diagnostic device itself.
No
The device description explicitly states that the device contains physical vials of material (serum, matrix, etc.) for in vitro diagnostic use, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The intended use explicitly states "for in vitro diagnostic use" for all listed calibration verification materials. This is the primary indicator of an IVD.
- Function: The device is intended for "verification of calibration" of specific assays (HCG, Insulin, Pyrilinks-D, Homocysteine, Growth Hormone) on the IMMULITE 2000 systems. These assays are used to measure substances in biological samples (like serum), which is a core function of in vitro diagnostics.
- Device Description: The device consists of materials (serum, matrices with added analytes) that are used in a laboratory setting to assess the performance of an in vitro diagnostic assay.
- Performance Studies: The performance studies described focus on aspects relevant to the reliability and accuracy of an IVD, such as stability, traceability, and value assignment.
- Predicate Devices: The listed predicate devices are also IVDs (e.g., CalCheck, Linearity Set), indicating that this type of product is classified as an IVD.
- Intended User / Care Setting: The mention of "For prescription use only" suggests use in a clinical laboratory setting, which is typical for IVDs.
Therefore, based on the provided information, the IMMULITE® Calibration Verification Materials are clearly intended and function as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
The IMMULITE® Insulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Insulin assay on the IMMULITE 2000 systems.
The IMMULITE® Pyrilinks-D Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Pyrilinks-D assay on the IMMULITE 2000 systems.
The IMMULITE® Homocysteine Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Homocysteine 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.
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 each 3mL. CVM1 contains HCG-free human serum with preservatives. CVM2. CVM3 and CVM4 contain HCG added to HCG-free human serum respectively, with preservatives.
The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVMI contains an equine serum matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of insulin in an equine serum matrix with preservatives.
The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM1 contains a phosphoric acid and sodium chloride matrix. CVM2, CVM3 and CVM4 contain various levels of H-Deoxypyridinoline in a phosphoric acid and sodium chloride matrix.
The Calibration Verification Material (CVM) contains one set of four vials, 2mL each. CVM 1 contains a bovine protein/buffer matrix with preservatives. CVM2, CVM3 and CVM4, contain various levels of s-adenosyl-L-homocysteine in a bovine protein/buffer matrix with preservatives.
The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM 1 contains an equine serum matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of human growth hormone in equine serum matrix with preservatives.
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)
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:
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IMMULITE 2000 HCG Calibration Verification Material: Stability study (up to 2.5 years when stored frozen at -20°C). Stability Protocol Summary: CVMs and reference CVMs run in duplicate at time points: 1, 548, 730, 912 days. Acceptance Criteria: Dose value of stability calibrator/CVM between ±12% of assigned dose for CVM level 2 and ±8% for CVM levels 3 and 4. Review limits: controls within 2SD of control target value. Traceability: WHO 3rd IS (75/537), qualified materials and measurement procedures. Value Assignment: 4 level materials, subset of 12 level HCG calibrators. Tested on 15 replicates (5 runs, 3 replicates/run) on 5 systems with 3 reagent kit lots. Expected Values/Reference Range: 15 replicates, 5 runs/3 replicates per run, 3 reagent kit lots, 5 instruments. Guildeline Range (95% CI) based on Target Mean ± 2SD. Expected assay range: 1 - 5000 mIU/mL.
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IMMULITE 2000 Insulin Calibration Verification Material: Stability study (up to 5 years when stored at -20°C). Stability Protocol Summary: CVMs and reference CVMs run in duplicate at time points: 1, 1280, 1460, 1825 days. Acceptance Criteria: Dose value between ±12% for CVM level 2, ±10% for CVM levels 3, and ±13% for CVM level 4. Review limits: controls within 2SD of control target value. Traceability: WHO NIBSC 1st IRP (66/304), qualified materials and measurement procedures. Value Assignment: 4 level materials, subset of 10 level Insulin calibrators. Tested on 26 replicates (9 runs, 2 or 3 replicates/run) on 7 systems with 5 reagent kit lots. Expected Values/Reference Range: 26 replicates, 9 runs/2 or 3 replicates per run, 5 reagent kit lots, 7 instruments. Guideline Range (95% CI) based on Target Mean ± 2SD. Expected assay range: 0.2 - 300 µIU/mL.
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IMMULITE 2000 Pyrilinks-D Calibration Verification Material: Stability study (up to 5 years when stored at -20°C). Stability Protocol Summary: CVMs and reference CVMs run in duplicate at time points: 1, 1280, 1460, 1642, 1825 days. Acceptance Criteria: Dose value between ±10% of assigned dose. Review limits: controls within 2SD of control target value. Traceability: Internal material gravimetrically prepared. Value Assignment: 4 level materials, subset of 8 level Pyrilinks-D calibrators. Tested on 15 replicates (5 runs, 3 replicates/run) on 4 systems with 3 reagent kit lots. Expected Values/Reference Range: 15 replicates, 5 runs/3 replicates per run, 3 reagent kit lots, 4 instruments. Guideline Range (95% CI) based on Target Mean ± 2SD. Expected assay range: 7 - 300 nmol/L.
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IMMULITE 2000 Homocysteine Calibration Verification Material: Stability study (up to 3.5 years when stored at -20°C). Stability Protocol Summary: CVMs and reference CVMs run in duplicate at time points: 730, 912, 1095, 1280 days. Acceptance Criteria: Dose value between ±15% for CVM level 2 and ±10% for CVM levels 3 and 4. Review limits: controls within 2SD of control target value. Traceability: Internal material gravimetrically prepared. Value Assignment: 4 level materials, subset of 7 level Homocysteine calibrators. Tested on 27 replicates (9 runs, 3 replicates/run) on 7 systems with 3 reagent kit lots. Expected Values/Reference Range: 27 replicates, 9 runs/3 replicates per run, 3 reagent kit lots, 7 instruments. Guideline Range (95% CI) based on Target Mean ± 2SD. Expected assay range: 2 - 50 µmol/L.
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IMMULITE 2000 Growth Hormone Calibration Verification Material: Stability study (up to 6 years when stored at 2-8°C). Stability Protocol Summary: CVMs and reference CVMs run in duplicate at time points: 1, 1280, 1642, 2190 days. Acceptance Criteria: Dose value between ±12% for CVM levels 2 and 4, ±10% for CVM level 3. Review limits: controls within 2SD of control target value. Traceability: WHO 2nd IS (98/574). Value Assignment: 4 level materials, subset of 9 level Growth Hormone calibrators. Tested on 27 replicates (9 runs, 3 replicates/run) on 7 systems with 4 reagent kit lots. Expected Values/Reference Range: 27 replicates, 9 runs/3 replicates per run, 4 reagent kit lots, 7 instruments. Guideline Range (95% CI) based on Target Mean ± 2SD. Expected assay range: 0.05 - 40 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.
K092168, K101075, K110061, K100715, K110061
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
Section 006: 510(k) Summary
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: _k133128
...
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- 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: Panel:
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Predicate Device Name Predicate 510(k) No:
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Device Description:
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- Intended Use: Indication for Use:
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591
- Intended Use: Indication for Use:
:
Asha Gartland Technical Regulatory Affairs Specialist (914)-524-3257 (914)-524-2101 asha.gartland@siemens.com October 16, 2013
OCT 22 2013
IMMULITE® 2000 HCG Calibration Verification Material Quality Control materials for IMMULITE® 2000 HCG assay Calibration Verification Material (CVM) for IMMULITE® 2000 HCG assav 21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Clinical Chemistry (75)
Elecsys HCG CalCheck 5 K092168
The Calibration Verification Material (CVM) contains One set of four vials each 3mL. CVM1 contains HCG-free human serum with preservatives. CVM2. CVM3 and CVM4 contain HCG added to HCG-free human serum respectively, with preservatives.
See Indications for Use Statement below:
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.
1
- Special Conditions for Use Statement(s): Special Instrument Requirements:
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- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
For prescription use only
IMMULITE® 2000 Systems
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 HCG Calibration Verification Material (CVM) is substantially equivalent to the predicate device as summarized in Table 1.
2
Table 1: Substantial Equivalence Comparison
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 HCG CVM | Predicate Device | |
| Elecsys HCG CalCheck 5 | ||
| Intended | ||
| Use | 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. | The Elecsys HCG CalCheck 5 is an | |
| assayed control for use in calibration | ||
| verification and for use in the | ||
| verification of the assay range | ||
| established by the Elecsys HCG+B | ||
| reagent and Elecsys HCG STAT reagent | ||
| on the indicated Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Analyte | HCG | Same |
| Matrix | Human Serum with preservatives | Same |
| Stability | Stable unopened until the expiration date | Same |
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 HCG CVM | Predicate Device | |
| Elecsys HCG CalCheck 5 | ||
| Form | Liquid | Lyophilized |
| Levels | 4 | 5 |
| Storage | ≤20°C | 2-8°C |
| Use | Single Use Only | Not For Single Use |
.
.
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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 shelf life claim for the IMMULITE 2000 HCG 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 IMMULITE® 2000 HCG Calibration Verification Materials are stable up to 2.5 years when stored frozen at -20℃ prior to opening.
7.1.1 Stability Protocol Summary:
The CVM study protocols are run as part of the calibrator stability testing. The stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Table 2 and the dose value determined from the reference calibrator curve.
| CVM Level | Time-Points (Days) | |||
|---|---|---|---|---|
| LCGCVM1 | 1 | 548 | 730 | 912 |
| LCGCVM2 | 1 | 548 | 730 | 912 |
| LCGCVM3 | 1 | 548 | 730 | 912 |
| LCGCVM4 | 1 | 548 | 730 | 912 |
Table 2: Stability Time Points
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE HCG Calibration Verification Material (CVM) consists of 2 parts. Part 1 consists of the Guideline acceptance criteria which require dose value of stability calibrator/CVM to fall between ±12% of assigned dose for CVM level 2 and ±8% of assigned dose for CVM levels 3 and 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 ±12% for level 2 and ±8% for levels 3 and 4 then additional data review is conducted using part 2 criteria. The acceptance criterion is summarized in Table 3.
Table 3 Acceptance criteria for stability of IMMULITE 2000 HCG CVM
| CVM Level | Assigned Dose (mIU/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (mIU/mL) | Review Limits |
|---|---|---|---|---|
| LCGCVM1 | 0.00 | N/A |