(35 days)
Not Found
No
The device description and performance studies focus on the chemical composition and stability of calibration materials, with no mention of AI/ML algorithms or data processing.
No
The device is a calibration verification material for in vitro diagnostic use, not a therapeutic device. It is used to verify the calibration of assays and does not treat or prevent disease.
No
Explanation: The device is described as "Calibration Verification Material (CVM)" for the verification of calibration of an assay. It is not used to diagnose a patient's condition directly but rather to ensure the accuracy of other diagnostic equipment. The "in vitro diagnostic use" specified refers to its use within the broader diagnostic process, not as a standalone diagnostic tool.
No
The device description clearly states that the device is a physical material (lyophilized form in vials) containing bovine protein and human albumin/myoglobin, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The IMMULITE® Albumin Calibration Material (CVM) is for in vitro diagnostic use..."
- "The IMMULITE® Myoglobin Calibration Verification Material (CVM) is for in vitro diagnostic use..."
This directly indicates that the device is intended for use in diagnostic procedures performed outside of the body.
N/A
Intended Use / Indications for Use
The IMMULITE® Albumin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Albumin assay on the IMMULITE 2000 systems
The IMMULITE® Myoglobin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Myoglobin assay on the IMMULITE 2000 systems
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Albumin Calibration Verification Material (CVM) contains one set of four vials each 2.0 mL after reconstitution. CVM1 contains bovine protein with preservatives. CVM2, CVM3 and CVM4 contain various levels of human albumin in a bovine protein matrix with preservatives. The CVMs are supplied in lyophilized form.
IMMULITE® 2000 Myoglobin Calibration Verification Material (CVM) contains one set of four vials each 2.0mL after reconstitution. CVM1 contains bovine serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of human cardiac myoglobin in bovine serum with preservatives. The CVMs are supplied in lyophilized form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
IMMULITE Albumin CVMs are 4 level materials which are a subset of 7 level Albumin calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of Albumin 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 Albumin antigen stock and are traceable to an internal material. Two levels of commercially available controls and 23 urine samples were used to validate calibrator/CVM value assignments.
The Myoglobin CVMs are 4 level materials which are a subset of 10 level Myoglobin calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of Myoglobin 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 Myoglobin antigen stock and are traceable to an internal standard. Three levels of commercially available controls and 30 samples (25 spiked samples and 5 normal samples) were used to validate calibrator/CVM value assignments.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IMMULITE 2000 Albumin Calibration Verification Material (CVM)
Shelf Life Stability Summary:
The stability study was conducted to validate real-time shelf life claim for the IMMULITE 2000 Albumin 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 Albumin Calibration Verification Materials are stable up to 6 years when stored at 2-8°C prior to reconstitution.
Shelf life 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.
Shelf Life Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Albumin requires dose value of stability calibrator/CVM to fall between ±10% of assigned dose for CVM level 2 and 3, and ±15% for CVM level 4.
Open Vial Stability Summary:
The stability study was conducted to validate open component (in-use or open vial) shelf life and open component (in-use or open vial) claim for the IMMULITE 2000 Albumin Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms after reconstitution. The IMMULITE® 2000 Albumin Calibration Verification Materials are stable up to 2 hours at ambient or room temperature (15-25°C) after reconstitution.
Open Vial Stability Protocol Summary:
The stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Table 4 and the dose value determined from the on system 2-point adjustment. Using IMMULITE 2000 Albumin (L2KHA2) kit lot 236 Albumin CVM lot 092 was tested up to 6 hours at ambient or room temperature (15-25°C) conditions and compared to the determinations at time zero.
Open Vial Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Albumin requires dose value of stability calibrator/CVM to fall between ±10% difference to the initial time point dose for CVM level 2 and 3, and ±15% to the initial time point does for CVM level 4.
Value Assignment:
The IMMULITE Albumin calibrators/CVMs were tested on 27 replicates in total, comprised of 9 runs, 3 replicates per run, 9 IMMULITE 2000 systems and 3 different reagent kit lots. The CVMs dose values are generated using the 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.
Expected Values/Reference Range:
Each CVM level was tested on 27 replicates in total, comprised of 9 runs, 3 replicates per run, 9 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 Standard Deviation (SD).
IMMULITE 2000 Myoglobin Calibration Verification Material (CVM)
Shelf life Stability Summary:
The stability study was conducted to validate shelf life claim for the IMMULITE 2000 Myoglobin 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 reconstitution. The Myoglobin Calibration Verification Materials are stable up to 7 years when stored at -20°C.
Shelf life 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.
Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Myoglobin criteria requires dose value of stability calibrator/CVM to fall between ±10% of assigned dose for CVM level 2, 3, and 4.
Open Vial Stability Summary:
The stability study was conducted to validate the open component (in-use or open vial) for the IMMULITE 2000 Myoglobin Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms after reconstitution. The Myoglobin Calibration Verification Materials are stable up to 8 hours after reconstitution.
Open Vial Stability Protocol Summary:
The stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Table 4 and the dose value determined from the on system 2-point adjustment.
Open Vial Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Myoglobin criteria requires dose value of stability calibrator/CVM to fall between ±10% difference to the initial time point dose for CVM level 2, 3, and 4.
Value Assignment:
The calibrators/CVMs were tested on 15 replicates in total, comprised of 5 runs, 3 replicates per run, 3 IMMULITE 2000 systems and 4 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.
Expected Values/Reference Range:
Each CVM level was on 15 replicates in total, comprised of 5 runs, 3 replicates per run, 3 IMMULITE 2000 systems and 4 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).
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.
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.
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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 a stylized image of an eagle with its wings spread, formed by three overlapping profiles of human faces.
January 14, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SIEMENS HEALTHCARE DIAGNOSTICS INC. SARA KASTRUP REGULATORY CLINICAL AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K143504
Trade/Device Name: IMMULITE® 2000 Albumin Calibration Verification Material, IMMULITE® 2000 Myoglobin Calibration Verification Material Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: December 9, 2014 Received: December 10, 2014
Dear Ms. Sara Kastrup:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.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,
Stayce Beck -S
For : 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K143504
Device Name
IMMULITE® 2000 Albumin Calibration Verification Material (CVM) IMMULITE® 2000 Myoglobin Calibration Verification Material (CVM)
Indications for Use (Describe)
The IMMULITE® Albumin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Albumin assay on the IMMULITE 2000 systems
The IMMULITE® Myoglobin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Myoglobin assay on the IMMULITE 2000 systems
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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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: _
-
- Submitter Mailing Address:
Contact Person:
- Submitter Mailing Address:
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:
- Device Description:
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591
Sara Kastrup Regulatory Clinical Affairs Specialist (914)-524-2317 (914)-524-2101 sara.kastrup@siemens.com December 9th, 2014
IMMULITE® 2000 Albumin Calibration Verification Material Quality Control materials for IMMULITE® 2000 Albumin assay Calibration Verification Material (CVM) for IMMULITE® 2000 Albumin assay
21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Clinical Chemistry (75)
IMMULITE® 2000 SHBG Calibration Verification Material (CVM)
The Albumin Calibration Verification Material (CVM) contains one set of four vials each 2.0 mL after reconstitution. CVM1 contains bovine protein with preservatives. CVM2, CVM3 and CVM4 contain various levels of human albumin in a bovine protein matrix with preservatives. The CVMs are supplied in lyophilized form.
4
| 5. Intended Use:
Indication for Use: | See Indications for Use Statement below:
The IMMULITE® Albumin Calibration Verification Material (CVM)
is for in vitro diagnostic use in the verification of calibration of the
IMMULITE Albumin assay on the IMMULITE 2000 systems. | | | | |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Special Conditions for | | | | | |
| Use Statement(s): | For prescription use only | | | | |
| Warnings and Precautions: | Caution, potential biohazard | | | | |
| | Contains human source material. Each donation of human blood or
blood component was tested by FDA-approved methods for the
presence of antibodies to human immunodeficiency virus type 1
(HIV-1) and type 2 (HIV-2) as well as for hepatitis B surface antigen
(HBsAg) and antibody to hepatitis C virus (HCV). The test results
were negative (not repeatedly reactive.). No test offers complete
assurance that these or other infectious agents are absent; this
material should be handled using good laboratory practices and
universal precautions. | | | | |
| Special Instrument | IMMULITE® 2000 Systems | | | | |
| Requirements: | | | | | |
| 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 Albumin
Calibration Verification Material (CVM) is substantially equivalent to
the predicate device as summarized in Table 1. | | | | |
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| Table 1: Substantial Equivalence Comparison | |||
|---|---|---|---|
| -- | -- | ---------------------------------------------- | -- |
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 Albumin CVM | Predicate Device | |
| IMMULITE 2000 SHBG CVM | ||
| Intended | ||
| Use | The IMMULITE® Albumin | |
| Calibration Verification Material | ||
| (CVM) is for in vitro diagnostic use in | ||
| the verification of calibration of the | ||
| IMMULITE Albumin 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. | ||
| Form | Lyophilized | Same |
| Stability | Stable unopened until the expiration | |
| date | Same | |
| Levels | 4 | Same |
| Use | Single Use Only | Same |
| Storage | 2-8°C | Same |
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 Albumin CVM | Predicate Device | |
| IMMULITE 2000 SHBG CVM | ||
| Analyte | Albumin | SHBG |
| Matrix | Bovine Protein with Preservatives | Buffered Bovine Protein with Preservatives |
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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 intended use. The following tests were performed on the candidate device.
7.1 Shelf Life Stability Summary:
The stability study was conducted to validate real-time shelf life claim for the IMMULITE 2000 Albumin 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 Albumin Calibration Verification Materials are stable up to 6 years when stored at 2-8°C prior to reconstitution.
7.1.1 Shelf life 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) | |||
|---|---|---|---|---|
| LHACVM1 | 0 | 54 | 72 | 84 |
| LHACVM2 | 0 | 54 | 72 | 84 |
| LHACVM3 | 0 | 54 | 72 | 84 |
| LHACVM4 | 0 | 54 | 72 | 84 |
Table 2: Shelf life Stability Time Points
7.1.2 Shelf Life Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Albumin requires dose value of stability calibrator/CVM to fall between ±10% of assigned dose for CVM level 2 and 3, and ±15% for CVM level 4. The acceptance criterion is summarized in Table 3.
| Table 3 Acceptance criteria for stability of IMMULITE 2000 Albumin CVM | ||||
|---|---|---|---|---|
| CVM level | Assigned
Dose
(ug/mL) | Guideline Criteria
% difference to
assigned dose | Acceptable
dose range
(ug/mL) | Review Limits |
|-----------|-----------------------------|--------------------------------------------------------|-------------------------------------|-------------------------------|
| LHACVM1 | 0.00 | Not Applicable |