(125 days)
Not Found
No
The document describes a calibration verification material for an immunoassay, which is a chemical reagent used to verify the accuracy of a laboratory test. There is no mention of AI/ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic (IVD) product used for verifying the calibration and reportable range of an assay, not for directly treating a condition or disease.
No
The device is a calibration verification material used to verify the calibration and reportable range of an ACTH assay, not to diagnose a condition in a patient.
No
The device description explicitly states the device contains physical vials with processed bovine protein matrix and ACTH, indicating it is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "for in vitro diagnostic use".
- Device Description: The device is a "Calibration Verification Material (CVM)" used in conjunction with an "IMMULITE ACTH assay on the IMMULITE 2000 systems". This indicates it's used to verify the performance of a diagnostic test.
- Performance Studies: The document describes performance studies related to "Stability Summary" and "Traceability", which are typical for IVD devices to ensure their reliability and accuracy.
- Value Assignment: The "Value Assignment" section details how the material is calibrated and validated, a crucial step for IVD products.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K060585) and name ("Elecsys ACTH CalCheck") is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process.
All these points align with the characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMULITE® ACTH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE ACTH assay on the IMMULITE 2000 systems.
Product codes
JJX
Device Description
The Calibration Verification Material (CVM) contains one set of four vials, 3 mL each. LACCVM1 contains processed bovine protein matrix with preservatives. LACCVM2, LACCVM3 and LACCVM4 contain low, intermediate and high levels of ACTH respectively, in processed bovine protein based 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
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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)
Stability Summary:
The stability study was conducted to validate the shelf life claim for the IMMULITE® 2000 ACTH Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platform throughout the established shelf life of the CVM. The IMMULITE® 2000 ACTH Calibration Verification Materials (CVMs) are stable up to 2 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.
Table 2: Stability Time Points:
| CVM Level | Time-Points (Days) |
|---|---|
| LACCVM1 | 1, 182, 548, 730 |
| LACCVM2 | 1, 182, 548, 730 |
| LACCVM3 | 1, 182, 548, 730 |
| LACCVM4 | 1, 182, 548, 730 |
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE 2000 ACTH Calibration Verification Material (CVM) consists of 2 parts. Part 1 consists of the Guideline Acceptance Criteria which requires the dose value stability CVM to fall between ±10% of the assigned dose. Part 2 consists of the Review Limits Acceptance Criteria which requires the dose value of the controls to be within 2SD of the control target value generated from the stability calibrator curve. If the result is not within the acceptable dose range of ±10%, then additional data review is performed using the part 2 acceptance criterion. The acceptance criteria is summarized in Table 3.
Table 3: Stability Acceptance Criteria for IMMULITE 2000 ACTH CVM
| CVM Level | Assigned Dose (pg/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (pg/mL) | Review Limits |
|---|---|---|---|---|
| LACCVM1 | 0.00 | ≤5.00 | ≤5.00 | Not Applicable |
| LACCVM2 | 21.8 | ±10 | 19.62 - 23.98 | Controls are within 2SD |
| LACCVM3 | 238 | ±10 | 214.20 - 261.80 | of target from stability |
| LACCVM4 | 1214 | ±10 | 1092.6 - 1335.40 | calibrator curve |
7.2 Traceability:
The IMMULITE® 2000 ACTH Calibration Verification Materials are traceable to internal assigned reference calibrators prepared using ACTH antigen stock solution and are traceable to internal material which is gravimetrically prepared. The CVMs are manufactured using qualified materials and measurement procedures.
7.3 Value Assignment:
ACTH CVMs are 4 level materials which are subset of 8 level ACTH calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of ACTH 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 recombinant human ACTH 1-39 antigen stock and are traceable to internal material which has been gravimetrically prepared. Two levels of commercially available controls, and 40 patient samples (5 normal patients samples and 35 spiked normal patients samples) are used to validate CVM value assignments.
The CVMs were tested on 27 replicates in total comprised of nine runs and three replicates per run on eight systems and four different reagent kit lots. The CVMs dose values are generated using. Surve 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.
7.4 Expected 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 8 different instruments were used to gain 27 replicates. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected values are provided in the IMMULITE® 2000 CVM Calibration verification Material lot-specific value card. The expected assay range is 5 - 1250 pg/mL. The target values in Table 4 can be considered as guidelines.
Table 4: Expected values of CVM levels
| Analyte target levels | Level | Target Mean (pg/mL) | Standard Deviation (SD) | Guideline ±2SD Range (pg/mL) |
|---|---|---|---|---|
| 1 | 0.00 | 0.00 - ≤5.00 | ||
| 2 | 21.8 | 2.2 | 17.4 - 26.2 | |
| 3 | 238 | 22.5 | 193 - 283 | |
| 4 | 1214 | 91 | 1032 - 1396 | |
| Assay Range | 5 -1250 pg/mL |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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SIEMENS
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:
Regulation Section: Classification: Products Code:
- Device Name Proprietary Name: Measurand: Type of Test:
Panel:
-
- Predicate Device Name Predicate 510(k) No:
-
- Device Description:
-
- Intended Use: Indication for Use:
Special Conditions for Use Statement(s): Special Instrument Requirements:
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591
Garo Mimaryan, MS, RAC Technical Regulatory Affairs Specialist III (914)-524-3270 (914)-524-2101 garo.mimaryan@siemens.com August 30, 2013
IMMULITE® 2000 ACTH Calibration Verification Material Quality Control materials for IMMULITE® 2000 ACTH assay Calibration Verification Material (CVM) for IMMULITE® 2000 ACTH assay 21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassaved) Clinical Chemistry (75)
Elecsys ACTH CalCheck K060585
The Calibration Verification Material (CVM) contains one set of four vials, 3 mL each. LACCVM1 contains processed bovine protein matrix with preservatives. LACCVM2, LACCVM3 and LACCVM4 contain low, intermediate and high levels of ACTH respectively, in processed bovine protein based matrix with preservatives.
See Indications for Use Statement below The IMMULITE® ACTH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE ACTH assay on the IMMULITE 2000 systems
For prescription use only
IMMULITE® 2000 Systems
OCT 1 0 2013
1
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 ACTH Calibration Verification Material (CVM) is substantially equivalent to the predicate device, Elecsys ACTH CalCheck, as summarized in Table 1.
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
| Table 1: Substantial Equivalence Comparison | |||
|---|---|---|---|
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 ACTH CVM | Predicate Device | |
| Elecsys ACTH CalCheck | ||
| Intended Use | The IMMULITE® ACTH Calibration | |
| Verification Material (CVM) is for in vitro | ||
| diagnostic use in the verification of calibration | ||
| and reportable range of the IMMULITE | ||
| ACTH assay on the IMMULITE 2000 systems | For use in the verification of the | |
| calibration established by the Elecsys | ||
| ACTH reagent on the indicated Elecsys | ||
| and cobas e immunoassay analyzers. | ||
| Analyte | ACTH | Same |
| Form | Lyophilized | Same |
| Traceability | Standardized gravimetrically | Same |
| DIFFERENCES | ||
| Stability | Stable until the expiration date when stored | |
| frozen. | Stable until the expiration date when | |
| stored refrigerated. | ||
| Storage | -20°C | 2-8°C |
| Matrix | Bovine protein based matrix with | |
| preservatives. | Buffered equine serum with preservatives. | |
| Use | Single Use Only | Not for Single Use |
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 the shelf life claim for the IMMULITE® 2000 ACTH Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platform throughout the established shelf life of the CVM. The IMMULITE® 2000 ACTH Calibration Verification Materials (CVMs) are stable up to 2 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) | | | |
|-----------|-----------------------|-----|-----|-----|
| LACCVM1 | 1 | 182 | 548 | 730 |
| LACCVM2 | 1 | 182 | 548 | 730 |
| LACCVM3 | 1 | 182 | 548 | 730 |
| LACCVM4 | 1 | 182 | 548 | 730 |
Table 2: Stability Time Points:
2
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE 2000 ACTH Calibration Verification Material (CVM) consists of 2 parts. Part 1 consists of the Guideline Acceptance Criteria which requires the dose value stability CVM to fall between ±10% of the assigned dose. Part 2 consists of the Review Limits Acceptance Criteria which requires the dose value of the controls to be within 2SD of the control target value generated from the stability calibrator curve. If the result is not within the acceptable dose range of ±10%, then additional data review is performed using the part 2 acceptance criterion. The acceptance criteria is summarized in Table 3.
| CVM Level | Assigned
Dose (pg/mL) | Guideline Criteria %
difference to assigned dose | Acceptable dose
range (pg/mL) | Review Limits |
|-----------|--------------------------|-----------------------------------------------------|----------------------------------|--------------------------|
| LACCVM1 | 0.00 | ≤5.00 | ≤5.00 | Not Applicable |
| LACCVM2 | 21.8 | ±10 | 19.62 - 23.98 | Controls are within 2SD |
| LACCVM3 | 238 | ±10 | 214.20 - 261.80 | of target from stability |
| LACCVM4 | 1214 | ±10 | 1092.6 - 1335.40 | calibrator curve |
Table 3: Stability Acceptance Criteria for IMMULITE 2000 ACTH CVM
7.2 Traceability:
The IMMULITE® 2000 ACTH Calibration Verification Materials are traceable to internal assigned reference calibrators prepared using ACTH antigen stock solution and are traceable to internal material which is gravimetrically prepared. The CVMs are manufactured using qualified materials and measurement procedures.
7.3 Value Assignment:
ACTH CVMs are 4 level materials which are subset of 8 level ACTH calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of ACTH 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 recombinant human ACTH 1-39 antigen stock and are traceable to internal material which has been gravimetrically prepared. Two levels of commercially available controls, and 40 patient samples (5 normal patients samples and 35 spiked normal patients samples) are used to validate CVM value assignments.
The CVMs are manufactured using qualified materials and measurement procedures. The CVMs were tested on 27 replicates in total comprised of nine runs and three replicates per run on eight systems and four different reagent kit lots. The CVMs dose values are generated using. Surve 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
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7.4 Expected 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 8 different instruments were used to gain 27 replicates. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected values are provided in the IMMULITE® 2000 CVM Calibration verification Material lot-specific value card. The expected assay range is 5 - 1250 pg/mL. The target values in Table 4 can be considered as guidelines.
| Analyte target levels | Level | Target Mean
(pg/mL) | Standard
Deviation
(SD) | Guideline ±2SD Range
(pg/mL) | |
|-----------------------|---------------|------------------------|-------------------------------|---------------------------------|-------|
| | 1 | 0.00 | | 0.00 | ≤5.00 |
| | 2 | 21.8 | 2.2 | 17.4 | 26.2 |
| | 3 | 238 | 22.5 | 193 | 283 |
| | 4 | 1214 | 91 | 1032 | 1396 |
| Assay Range | 5 -1250 pg/mL | | | | |
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 ACTH Calibration Verification Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys ACTH CalCheck. 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, Elecsys ACTH CalCheck, The IMMULITE® 2000 ACTH 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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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The text is in all capital letters and is smaller than the eagle symbol. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
October 10, 2013
Siemens Healthcare Diagnostics, Inc. c/o Garo Mimaryan 511 Benedict Ave TARRYTOWN NY 10591-5097
Re: K131662
Trade/Device Name: Immulite 2000 ACTH Calibration Verification Material Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Codc: JJX Dated: September 10, 2013 Received: September 11, 2013
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 cnactment 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 misJeading,
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 (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 1000-1 050.
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Page 2—Garo Mimaryan
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/McdicalDevices/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/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 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,
Carol C. Benson -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
6
Indications for Use
510(k) Number (if known): kl31662
Device Name: IMMULITE®2000 ACTH Calibration Verification Material
Indication for Use:
The IMMULITE® ACTH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE ACTH assay on the IMMULITE 2000 systems
Prescription Use_X_ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use_ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung-W.Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131662