(49 days)
Not Found
No
The document describes calibration verification materials for an immunoassay system, which are chemical reagents used to check the accuracy of the instrument's calibration. There is no mention of AI or ML in the intended use, device description, or performance studies. The calculations described are standard statistical methods for averaging and quality control in laboratory assays.
No
This device is for in vitro diagnostic use, specifically for the verification of calibration of assays, and does not directly provide therapy for a medical condition.
No
This device is described as a "Calibration Verification Material (CVM) for in vitro diagnostic use in the verification of calibration of the IMMULITE Rubella Quantitative IgG assay on the IMMULITE 2000 systems." It is used to ensure the accuracy of other diagnostic assays, not to directly diagnose a condition itself.
No
The device description explicitly states the device contains vials with liquid materials (human serum, bovine protein matrix, preservatives) which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the material is "for in vitro diagnostic use". This is the primary indicator that the device falls under the category of IVDs.
While the device itself is a calibration verification material and not a diagnostic test that directly analyzes patient samples for a diagnosis, it is intended to be used with an in vitro diagnostic assay (the IMMULITE Rubella, H. pylori, and Toxoplasma IgG assays) to ensure the accuracy and reliability of those diagnostic results. Therefore, it is considered an IVD accessory or component.
N/A
Intended Use / Indications for Use
The IMMULITE® Rubella Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Rubella Quantitative IgG assay on the IMMULITE 2000 systems.
The IMMULITE® H. pylori IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE H. pylori IgG assay on the IMMULITE 2000 systems.
The IMMULITE® Toxoplasma Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Toxoplasma Quantitative IgG assay on the IMMULITE 2000 systems.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
IMMULITE® 2000 Rubella Quantitative IgG Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials each 1.0mL. CVM1 contains negative Rubella IgG in human serum and a buffered bovine protein matrix with preservatives. CVM2, CVM 3 and CVM4 contain various levels of Rubella IgG in human serum and buffered bovine protein matrix with preservatives.
IMMULITE® 2000 H. pylori IgG Calibration Verification Material (CVM) contains one 1 mL vial. CVM 1 contains H. pylori IgG in human serum and a buffered bovine protein matrix with preservatives.
IMMULITE® 2000 Toxoplasma Quantitative IgG Calibration Verification Material: The Calibration Verification Material (CVM) contains one set of four vials, 1 mL each. CVM1 contains negative Toxoplasma IgG in human serum in a bovine protein/buffer matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of Toxoplasma IgG in human serum in a bovine protein/buffer matrix with preservatives.
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
Rubella Quantitative IgG CVM:
The IMMULITE® 2000 Rubella Quantitative IgG Calibration Verification Materials are stable up to up to 30 months (2.5 years) when stored at -20°C prior to opening and for 8 hours at ambient or room temperature (15-25°C) after opening.
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: 0, 18, 24, 30 months. The dose value determined from the reference calibrator curve.
For Open Component testing, the results are determined from 2-point adjustment. Using IMMULITE 2000 Rubella Quantitative IgG kit (L2KRUB) lot 432, CVM lot 090 were tested at 2hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.
H. pylori IgG CVM:
The H. pylori IgG Calibration Verification Material is stable up to 24 months (2 years) when stored at -20°C prior to opening, and stable for 8 hours at ambient or room temperature (15-25°C) after opening.
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: 0, 12, 18, 24 months. The dose value determined from the reference calibrator curve.
For Open Component testing, the results are determined from 2-point adjustment. Using IMMULITE 2000 H. pylori IgG (L2KHPG) kit Lot 341, the Lot 090 CVM was tested at 2hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.
Toxoplasma Quantitative IgG CVM:
The IMMULITE® 2000 Toxoplasma Quantitative IgG Calibration Verification Materials (CVMs) are up 3 years when stored at -20℃ prior to opening and stable for 8 hours at ambient or room temperature (15-25℃) after opening.
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: 0, 24, 30, 36 months. The dose value determined from the reference calibrator curve.
For Open Component testing, the results are determined from 2-point adjustment. Using L2KTXP Kit Lot 394, Lot 090 CVMs were tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing for Stability.
Rubella Quantitative IgG CVM:
The Acceptance Criteria for the IMMULITE Rubella IgG CVM are in 2 parts. Part 1 consists of guideline acceptance criteria which require dose value of stability calibrator/CVM levels 2 and 3 to fall between ±15% of assigned dose and ±20% of assigned dose for level 4. Part 2 review limits criteria require dose value of the controls to be within 2 Standard Deviation (SD) 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 ±20% for level 4 then additional data review is conducted using part 2 criteria.
H. pylori IgG CVM:
The Acceptance Criteria for the IMMULITE H. pylori IgG CVM criteria require the dose value of stability calibrator/CVM to fall within ±10% of the assigned dose.
Toxoplasma Quantitative IgG CVM:
The Acceptance Criteria for the IMMULITE 2000 Toxoplasma Quantitative IgG CVM are in 2 parts. Part 1 consists of guideline acceptance criteria which require dose value of stability calibrator/CVM levels 2 and 3 to fall between ±10% of assigned dose and ±24% for level 4. Part 2 review limits criteria require dose value of the controls to be within 2 Standard Deviations (SD) 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 and ±24% for level 4 then additional data review is conducted using part 2 criteria.
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.
IMMULITE® 2000 HCG Calibration Verification Material (CVM) K133128
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.
Not Found
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
Image /page/0/Picture/1 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 an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19,2014
SIEMENS HEALTHCARE DIAGNOSTICS INC. ASHA GARTLAND 511 BENEDICT AVE. TARRYTOWN NY 10591
Re: K141772 Trade/Device Name: IMMULITE® 2000 Rubella Quantitative IgG Calibration Verification Material IMMULITE® 2000 H. pylori IgG Calibration Verification Material IMMULITE® 2000 Toxoplasma Quantitative IgG Calibration Verification Material Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: June 30, 2014 Received: July 1, 2014
Dear Ms. Gartland:
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 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
1
electronic 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 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/Resourcesfor You/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.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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.
Sincerely yours,
Sally A. Hojvat -S
Sally A. Hojvat, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K141772
Device Name:
IMMULITE® 2000 Rubella Quantitative IgG Calibration Verification Material IMMULITE® 2000 H. pylori IgG Calibration Verification Material IMMULITE® 2000 Toxoplasma Quantitative IgG Calibration Verification Material
Indications for Use:
The IMMULITE® Rubella Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Rubella Quantitative IgG assay on the IMMULITE 2000 systems.
The IMMULITE® H. pylori IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE H. pylori IgG assay on the IMMULITE 2000 systems.
The IMMULITE® Toxoplasma Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Toxoplasma Quantitative IgG assay on the IMMULITE 2000 systems.
| Prescription Use
(21 CFR Part 801 Subpart D) | And/Or | Over the Counter Use
(21 CFR Part 801 Subpart C) |
|-------------------------------------------------|--------|-----------------------------------------------------|
| X_ | | _ |
3
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: | K141772 |
|---|---|
| 1. Submitter | |
| Mailing Address: | Siemens Healthcare Diagnostics Inc |
| 511 Benedict Avenue | |
| Tarrytown, NY 10591 |
Asha Gartland Technical Regulatory Affairs Specialist (914)-524-3257 (914)-524-2101 asha.gartland(@siemens.com June 30, 2014
IMMULITE® 2000 Rubella Quantitative IgG Calibration Verification Material
Quality Control materials for IMMULITE® 2000 Rubella Quantitative IgG assay Calibration Verification Material (CVM) for IMMULITE® 2000 Rubella Quantitative IgG assay 21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Microbiology (83)
IMMULITE® 2000 HCG Calibration Verification Material (CVM) K133128
The Calibration Verification Material (CVM) contains one set of four vials each 1.0mL. CVM1 contains negative Rubella IgG in human serum and a buffered bovine protein matrix with preservatives. CVM2, CVM 3 and CVM4 contain various levels of Rubella IgG in human serum and buffered bovine protein matrix with preservatives.
Contact Person:
Phone Number: Fax Number: E-mail Address: Date Prepared:
-
- Device Name Proprietary Name: Measurand:
Type of Test:
- Device Name Proprietary Name: Measurand:
Regulation Section: Classification: Products Code: Panel:
- Predicate Device Name Predicate 510(k) No:
4. Device Description:
4
Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The word is presented in all capital letters and is horizontally oriented.
| 5. Intended Use: | See Indications for Use Statement below: |
|---|---|
| Indication for Use: | The IMMULITE® Rubella Quantitative IgG Calibration Verification |
| Material (CVM) is for in vitro diagnostic use in the verification of | |
| calibration of the IMMULITE Rubella Quantitative IgG assay on the | |
| IMMULITE 2000 systems. | |
| Special Conditions for | |
| Use Statement(s): | |
| Special Instrument | For prescription use only |
| Requirements: | IMMULITE® 2000 Systems |
| 6. Technological Characteristics | |
| and Substantial Equivalence | A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 Rubella Quantitative IgG Calibration Verification Material (CVM) is substantially equivalent to the predicate device as summarized in |
| Comparison with Predicate: |
Table 1.
5
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 Rubella | ||
| Quantitative IgG CVM | Predicate Device | |
| IMMULITE 2000 HCG CVM | ||
| Intended | ||
| Use | The IMMULITE® Rubella | |
| Quantitative IgG Calibration | ||
| Verification Material (CVM) is for in | ||
| vitro diagnostic use in the verification | ||
| of calibration of the IMMULITE | ||
| Rubella Quantitative IgG 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 |
| Storage | ≤20°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 Rubella | ||
| Quantitative IgG CVM | Predicate Device | |
| IMMULITE 2000 HCG CVM | ||
| Analyte | Rubella IgG | HCG |
| Matrix | Human serum with Bovine protein and | |
| preservatives | Human serum with preservatives |
6
7. Non-Clinical Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the candidate device.
7.1 Stability Summary:
The stability study was conducted to validate the real-time shelf life and In-Use (Open Component or open vial) claim for the IMMULITE 2000 Rubella Quantitative IgG Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM before and after opening. The IMMULITE® 2000 Rubella Quantitative IgG Calibration Verification Materials are stable up to up to 30 months (2.5 years) when stored at -20°C prior to opening and for 8 hours at ambient or room temperature (15-25°C) after 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 (months) | |||
|---|---|---|---|---|
| LRUBCVM1 | 0 | 18 | 24 | 30 |
| LRUBCVM2 | 0 | 18 | 24 | 30 |
| LRUBCVM3 | 0 | 18 | 24 | 30 |
| LRUBCVM4 | 0 | 18 | 24 | 30 |
Table 2: Stability Time Points
For Open Component testing, the results are determined from 2-point adjustment. Using IMMULITE 2000 Rubella Quantitative IgG kit (L2KRUB) lot 432, CVM lot 090 were tested at 2hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Rubella IgG CVM are in 2 parts. Part 1 consists of guideline acceptance criteria which require dose value of stability calibrator/CVM levels 2 and 3 to fall between ±15% of assigned dose and ±20% of assigned dose for level 4. Part 2 review limits criteria require dose value of the controls to be within 2 Standard Deviation (SD) 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 ±20% for level 4 then additional data review is conducted using part 2 criteria. The acceptance criterion is summarized in Table 3.
7
| CVM level | Assigned
Dose
(IU/mL) | *Guideline Criteria
% difference to
assigned dose | Acceptable dose
range
(IU/mL) | **Review
Limits |
|-----------|-----------------------------|---------------------------------------------------------|-------------------------------------|----------------------------------------------------------|
| LRUBCVM1 | 0.00 | Not Applicable | ≤5.00 | Controls are
within 2SD
of target on
each curve |
| LRUBCVM2 | 9.00 | ±15% | 7.65 - 10.4 | Controls are
within 2SD
of target on
each curve |
| LRUBCVM3 | 245 | ±15% | 208 – 282 | Controls are
within 2SD
of target on
each curve |
| LRUBCVM4 | 505 | ±20% | 404 - 606 | Controls are
within 2SD
of target on
each curve |
Table 3 Acceptance criteria for stability of IMMULITE 2000 Rubella Quantitative IgG CVM
7.2 Traceability:
The IMMULITE Rubella Quantitative IgG CVMs are traceable to WHO 1st IS RUBI-1-94. The CVMs are manufactured using qualified materials and measurement procedures.
7.3 Value Assignment:
IMMULITE Rubella Quantitative IgG CVMs are 4 level materials which are a subset of 7 level Rubella Quantitative IgG calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of Rubella Quantitative IgG 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 Rubella Quantitative IgG antigen stock and are traceable to WHO 1st IS RUBI-1-94. Three levels of commercially available controls and 42 patient serum samples were used to validate calibrator/CVM value assignments.
The CVMs are manufactured using qualified materials and measurement procedures. The IMMULITE Rubella Quantitative IgG calibrators/CVMs were tested on 15 replicates in total, comprised of 5 runs, 3 replicates per run, 4 systems and 3 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 controls must fall within their target ranges.
7.4 Expected Values/Reference Range:
Each CVM level was tested on 15 replicates in total comprised of 5 runs, 3 replicates per run, 4 systems and 3 different reagent kit lots. 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 CVM Calibration Verification Material lot-specific package insert.
8
The expected assay range is 5 to 400 IU/mL. The target values in Table 4 can be considered as guidelines.
| Analyte
target levels | CVM Level | Target Mean
(IU/mL) | Standard
Deviation
(SD) | Guideline ±2SD Range
(IU/mL) | |
|--------------------------|----------------|------------------------|-------------------------------|---------------------------------|------|
| | LRUBCVM1 | 0.00 | - | 0.00 $\leq$ 5.00 | |
| | LRUBCVM2 | 9.15 | 0.92 | 7.32 | 11.0 |
| | LRUBCVM3 | 195 | 14.5 | 166 | 224 |
| | LRUBCVM4 | 425 | 42.5 | 340 | 510 |
| Assay Range | 5 to 400 IU/mL | | | | |
Table 4: Target Values
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 Rubella Quantitative IgG Calibration Verification Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the FDA cleared IMMULITE® 2000 HCG 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 Rubella Quantitative IgG Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
9
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: K141772
| 1. Submitter | |
|---|---|
| Mailing Address: | Siemens Healthcare Diagnostics Inc. |
| 511 Benedict Avenue | |
| Tarrytown, NY 10591 | |
| Contact Person: | Asha Gartland |
| Technical Regulatory Affairs Specialist | |
| Phone Number: | (914)-524-3257 |
| Fax Number: | (914)-524-2101 |
| E-mail Address: | asha.gartland@siemens.com |
| Date Prepared: | June 30th, 2014 |
| 2. Device Name | |
| Proprietary Name: | IMMULITE® 2000 H. pylori IgG Calibration Verification Material |
| Measurand: | Material |
| Type of Test: | Quality Control material for IMMULITE® 2000 H. pylori IgG assay |
| Calibration Verification Material (CVM) for IMMULITE® 2000 | |
| H. pylori IgG 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: | Microbiology (83) |
| 3. Predicate Device Name | IMMULITE® 2000 HCG Calibration Verification Material (CVM) |
| Predicate 510(k) No: | K133128 |
| 4. Device Description: | IMMULITE® 2000 H. pylori IgG Calibration Verification Material (CVM) contains one 1 mL vial. CVM 1 contains H. pylori IgG in human serum and a buffered bovine protein matrix with preservatives. |
| 5. Intended Use: | |
| Indication for Use: | See Indications for Use Statement below |
| The IMMULITE® H. pylori IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE H. pylori IgG assay on the IMMULITE 2000 systems. | |
| Special Conditions for | |
| Use Statement(s): | For prescription use only |
| Special Instrument | |
| Requirements: | IMMULITE® 2000 Systems |
| 6. Technological |
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Image /page/10/Picture/0 description: The image shows the word "SIEMENS" in a large, sans-serif font. The letters are a teal color, and the word is underlined with a thin black line. The background is white.
| Characteristics and
Substantial Equivalence
Comparison with Predicate: | A comparison of the device features, intended use, and other
information demonstrates that the IMMULITE® 2000 H. pylori IgG
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 H. pylori IgG CVM | Predicate Device | |
| IMMULITE 2000 HCG CVM | ||
| Intended Use | The IMMULITE® H. pylori IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE H. pylori IgG 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 |
| Storage | ≤20°C | Same |
| Stability | Stable unopened until the expiration date | Same |
| Levels | 4 | Same |
| Use | Single Use Only | Same |
| Form | Liquid | Same |
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 H. pylori IgG CVM | Predicate Device | |
| IMMULITE 2000 HCG CVM | ||
| Analyte | H. pylori IgG | HCG |
| Matrix | Human serum with Bovine protein and | |
| preservatives | Human serum with preservatives |
11
7. Non-Clinical Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the candidate device.
7.1 Stability Summary:
The stability study was conducted to validate real-time shelf life and open component (in-use or open vial) for the IMMULITE 2000 H. pylori IgG Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM, before and after opening.
The H. pylori IgG Calibration Verification Material is stable up to 24 months (2 years) when stored at -20°C prior to opening, and stable for 8 hours at ambient or room temperature (15-25°C) after 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 (months) | |||
|---|---|---|---|---|
| LHPGCVM1 | 0 | 12 | 18 | 24 |
| LHPGCVM1 | 0 | 12 | 18 | 24 |
| LHPGCVM1 | 0 | 12 | 18 | 24 |
| LHPGCVM1 | 0 | 12 | 18 | 24 |
Table 2: Stability Time Points
For Open Component testing, the results are determined from 2-point adjustment. Using IMMULITE 2000 H. pylori IgG (L2KHPG) kit Lot 341, the Lot 090 CVM was tested at 2hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE H. pylori IgG CVM criteria require the dose value of stability calibrator/CVM to fall within ±10% of the assigned dose.
The acceptance criterion is summarized in Table 3.
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| CVM level | Assigned
Dose
(U/mL) | Guideline
Criteria
% difference to
assigned dose | Acceptable
dose range
(U/mL) |
|-----------|----------------------------|-----------------------------------------------------------|------------------------------------|
| LHPGCVM1 | 1.07 | ±10% | 0.96 – 1.18 |
|--|
7.2 Traceability:
The IMMULITE H. pylori IgG CVM is traceable to an internal standard which has been gravimetrically prepared. The CVMs are manufactured using qualified materials and measurement procedures.
7.3 Value Assignment:
H. pylori IgG CVM is a single level material; one level of 7 level H. pylori IgG calbrators. Calibrators are not commercialized but are used internally during manufacture and release testing of H. pylori IgG 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 H. pvlori IgG antigen stock and are traceable to an internal material which has been gravimetrically prepared. Three levels of commercially available controls and 24 patient serum samples were used to validate calibrator/CVM value assignments.
The CVMs are manufactured using qualified materials and measurement procedures. The calibrators/CVMs were tested on 15 replicates in total, comprised of 5 runs, 3 replicates per run, 4 IMMULITE 2000 systems and 3 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. CVM values are then averaged across all systems. Ouality 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.
7.4 Expected Values/Reference Range:
Each CVM level was tested 15 replicates in total, comprised of 5 runs, 3 replicates per run, 4 IMMULITE 2000 systems and 3 different reagent kit lots. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2
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Standard Deviation (SD). The expected values are provided in the IMMULITE® 2000 CVM Calibration Verification Material lot-specific package insert. The expected assay range is 0.4 to 8.0 U/mL. The target values in Table 4 can be considered as guidelines.
| Analyte target
levels | CVM Level | Target (U/mL) | Standard
Deviation
(SD) | Guideline ±2SD
Range
(U/mL) |
|--------------------------|-----------------|---------------|-------------------------------|-----------------------------------|
| | LHPGCVM1 | 1.07 | 0.05425 | 0.963 1.18 |
| Assay Range | 0.4 to 8.0 U/mL | | | |
| Table 4: Target Values |
|---|
| ------------------------- |
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 H. pylori IgG Calibration Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the FDA cleared IMMULITE® 2000 HCG 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 H. pylori IgG 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: K141772
| 1. Submitter
Mailing Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 |
|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Phone Number:
Fax Number:
E-mail Address:
Date Prepared: | Asha Gartland
Technical Regulatory Affairs Specialist
(914)-524-3257
(914)-524-2101
asha.gartland@siemens.com
June 30th, 2014 |
| 2. Device Name
Proprietary Name:
Measurand:
Type of Test:
Regulation Section:
Classification:
Products Code:
Panel: | IMMULITE® 2000 Toxoplasma Quantitative IgG Calibration
Verification Material
Quality Control materials for IMMULITE® 2000 Toxoplasma
Quantitative IgG assay
Calibration Verification Material (CVM) for IMMULITE® 2000
Toxoplasma Quantitative IgG assay
21 CFR 862.1660, Quality Control Material
Class I Reserved
JJX - Single (Specified) Analyte Controls (Assayed and
Unassayed)
Microbiology (83) |
| 3. Predicate Device Name | IMMULITE® 2000 HCG Calibration Verification Material (CVM)
K133128 |
| Predicate 510(k) No:
4. Device Description: | The Calibration Verification Material (CVM) contains one set of
four vials, 1 mL each. CVM1 contains negative Toxoplasma IgG
in human serum in a bovine protein/buffer matrix with
preservatives. CVM2, CVM3 and CVM4 contain various levels of
Toxoplasma IgG in human serum in a bovine protein/buffer matrix
with preservatives. |
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| 5. Intended Use:
Indication for Use: | See Indications for Use Statement below
The IMMULITE® Toxoplasma Quantitative IgG Calibration
Verification Material (CVM) is for in vitro diagnostic use in the
verification of calibration of the IMMULITE Toxoplasma
Quantitative IgG assay on the IMMULITE 2000 systems |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Special Conditions for
Use Statement(s):
Special Instrument
Requirements: | 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 Toxoplasma
Quantitative IgG Calibration Verification Material (CVM) is
substantially equivalent to the predicate device as summarized in
Table 1. |
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| SIMILARITIES | |||
|---|---|---|---|
| Candidate Device | |||
| IMMULITE 2000 Toxoplasma | |||
| Quantitative IgG CVM | Predicate Device | ||
| IMMULITE HCG CVM | |||
| Intended | |||
| Use | The IMMULITE® Toxoplasma | ||
| Quantitative IgG CVM Calibration | |||
| Verification Material (CVM) is for in | |||
| vitro diagnostic use in the verification of | |||
| calibration of the IMMULITE | |||
| Toxoplasma Quantitative IgG 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 | |
| Stability | Stable unopened until the expiration date | Same | |
| Use | Single Use Only | Same | |
| Storage |