(32 days)
No
The document describes a calibration verification material for an in vitro diagnostic assay. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on stability and calibration verification, not algorithmic performance.
No
This device is for in vitro diagnostic use, specifically for the verification of calibration of an assay, not for treating a disease or condition in a patient.
No
Explanation: The device is a "Calibration Verification Material" used to verify the calibration of an assay, not to diagnose a condition directly.
No
The device description clearly states it is a material (lyophilized processed human serum) in vials, which is a physical substance, 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" used to verify the calibration of an assay (IMMULITE CEA assay) performed on a laboratory system (IMMULITE 2000 systems). This is a typical function of an IVD accessory or control material.
- Regulatory Information: The mention of a "Predicate Device(s)" with a K number (K140258) indicates that this device has gone through a regulatory submission process, which is required for IVDs.
Therefore, based on the provided information, this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IMMULITE® CEA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE CEA assay on the IMMULITE 2000 systems.
Product codes
JJX
Device Description
The CEA Calibration Verification Material (CVM) contains one set of four vials each 1.0mL after reconstitution. CVM1 contains lyophilized processed human serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of human CEA in a lyophilized processed human serum 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability Study:
The stability study was conducted to validate real-time shelf life and open component (in-use or open vial) claim for the IMMULITE 2000 CEA 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 IMMULITE® 2000 CEA Calibration Verification Materials are stable up to 6 years when stored at -20°C prior to opening and for 8 hours at ambient or room temperature (15-25°C) after reconstitution.
Protocol Summary: The CVM study protocols are run as part of the calibrator stability testing. Three lots of stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Tables 2a, 2b and 2c and the dose value determined from the reference calibrator curve.
For Open Component testing, the results are determined from a 2-point adjustment. Using IMMULITE 2000 CEA kit lot 290, CEA CVM lot 090 was tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions and compared to the determinations at time zero.
Acceptance Criteria Summary: The Acceptance Criteria for the IMMULITE CEA CVM real time and open component stability testing is applied to dose compared to dose at time point zero. The result is required to fall between ±10% difference for CVM levels 2 and 3 and ±15% for CVM level 4.
If the guideline criteria fail, then the stability is assessed on analyte drift as described below:
- If the slope is not significant (p ≥ 0.05), the stability estimate is the study duration less one time unit.
- If the slope is significant (p
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2015
Siemens Healthcare Diagnostics Inc. c/o Ms. Asha Gartland Technical Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K143639
Trade/Device Name: IMMULITE® 2000 CEA 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: December 19, 2014 Received: December 22, 2014
Dear Ms. Gartland,
This letter corrects our substantially equivalent letter of January 23, 2015.
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. Iisting 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
1
CFR Part 807); labeling (21 CFR Part 801); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (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 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.
Leonthena R. Carrington -S
Leonthena Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K143639 |
|---|---|
| Device Name | IMMULITE® 2000 CEA Calibration Verification Material |
| Indications for Use (Describe) | The IMMULITE® CEA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE CEA assay on the IMMULITE 2000 systems. |
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
3
SIEME
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: K143639
| 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: | January 20th, 2015 |
-
- 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:
IMMULITE® 2000 CEA Calibration Verification Material Quality Control materials for IMMULITE® 2000 CEA assay Calibration Verification Material (CVM) for IMMULITE® 2000 CEA assay
21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Immunology (82)
IMMULITE® 2000 DHEA-SO4 Calibration Verification Material (CVM) K140258
The CEA Calibration Verification Material (CVM) contains one set of four vials each 1.0mL after reconstitution. CVM1 contains lyophilized processed human serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of human CEA in a lyophilized processed human serum matrix with preservatives.
4
-
- Intended Use: Indication for Use:
Special Conditions for Use Statement(s): Special Instrument Requirements:
- Intended Use: Indication for Use:
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
See Indications for Use Statement below: The IMMULITE® CEA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE CEA assay on the IMMULITE 2000 systems.
For prescription use only
IMMULITE® 2000 Systems
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 CEA Calibration Verification Material (CVM) is substantially equivalent to the predicate device as summarized in Table 1.
5
Table 1: Substantial Equivalence Comparison
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 CEA CVM | Predicate Device | |
| IMMULITE 2000 DHEA-SO4 | ||
| CVM | ||
| Intended | ||
| Use | The IMMULITE® CEA Calibration | |
| Verification Material (CVM) is for in | ||
| vitro diagnostic use in the verification | ||
| of calibration of the IMMULITE CEA | ||
| assay on the IMMULITE 2000 | ||
| systems. | The IMMULITE® DHEA-SO4 | |
| Calibration Verification Material | ||
| (CVM) is for in vitro diagnostic use | ||
| in the verification of calibration of | ||
| the IMMULITE DHEA-SO4 assay | ||
| on the IMMULITE 2000 systems. | ||
| Form | Lyophilized | Same |
| Storage | ≤-20°C | Same |
| Matrix | Human Serum with preservatives | Same |
| Stability | Stable unopened until the | |
| expiration date | Same | |
| Levels | 4 | Same |
| Use | Single Use Only | Same |
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE 2000 CEA CVM | Predicate Device | |
| IMMULITE 2000 DHEA-SO4 | ||
| CVM | ||
| Analyte | CEA | DHEA-SO4 |
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 real-time shelf life and open component (in-use or open vial) claim for the IMMULITE 2000 CEA 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 IMMULITE® 2000 CEA Calibration Verification Materials are stable up to 6 years when stored at -20°C prior to opening and for 8 hours at ambient or room temperature (15-25°C) after reconstitution.
7.1.1 Stability Protocol Summary:
The CVM study protocols are run as part of the calibrator stability testing. Three lots of stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Tables 2a. 2b and 2c and the dose value determined from the reference calibrator curve.
| CVM level | Time-Points (months) | |||
|---|---|---|---|---|
| LCECVM1 | Day 0 | 60 | 72 | 108 |
| LCECVM2 | Day 0 | 60 | 72 | 108 |
| LCECVM3 | Day 0 | 60 | 72 | 108 |
| LCECVM4 | Day 0 | 60 | 72 | 108 |
Table 2a: Stability Time Points for CEA CVM lot 006
Table 2b: Stability Time Points for CEA CVM lot 007
| CVM level | Time-Points (months) | |||
|---|---|---|---|---|
| LCECVM1 | Day 0 | 48 | 60 | 84 |
| LCECVM2 | Day 0 | 48 | 60 | 84 |
| LCECVM3 | Day 0 | 48 | 60 | 84 |
| LCECVM4 | Day 0 | 48 | 60 | 84 |
7
| CVM level | Time-Points (months) | |||
|---|---|---|---|---|
| LCECVM1 | Day 0 | 4 | 5 | 6 |
| LCECVM2 | Day 0 | 4 | 5 | 6 |
| LCECVM3 | Day 0 | 4 | 5 | 6 |
| LCECVM4 | Day 0 | 4 | 5 | 6 |
Table 2c: Stability Time Points for CEA CVM lot 090
For Open Component testing, the results are determined from a 2-point adjustment. Using IMMULITE 2000 CEA kit lot 290, CEA CVM lot 090 was tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions and compared to the determinations at time zero.
7.1.2 Stability Acceptance Criteria Summary:
The guideline criteria for samples stored over time at -20°C is outlined in Table 3.
The Acceptance Criteria for the IMMULITE CEA CVM real time and open component stability testing is applied to dose compared to dose at time point zero. The result is required to fall between ±10% difference for CVM levels 2 and 3 and ±15% for CVM level 4.
If the guideline criteria fail, then the stability is assessed on analyte drift as described below:
- If the slope is not significant (p ≥ 0.05), the stability estimate is the study duration less one time unit.
- If the slope is significant (p