(93 days)
No
The document describes a calibration verification and linearity test kit for Heparin Anti-Xa activity. The description focuses on the chemical composition, intended use as a quality control material, and performance studies related to precision, reproducibility, and stability. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: The device is an in vitro diagnostic (IVD) quality control material used for linearity and calibration verification of Heparin Anti-Xa activity tests on automated instruments in a clinical laboratory setting. It is not used directly on a patient for diagnosis, treatment, or prevention of disease.
No
This device is described as an "assayed quality control material" intended for "linearity, calibration verification and verification of reportable range for Heparin Anti-Xa activity." It is used to ensure the accuracy of instruments that perform diagnostic tests, rather than performing a diagnostic test itself.
No
The device is a test kit containing liquid solutions in a human plasma base matrix, which are physical components, 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 that the kit solutions are "intended for in vitro diagnostic use".
- Purpose: The purpose is to determine linearity, calibration verification, and verification of reportable range for Heparin Anti-Xa activity on automated instruments in a clinical laboratory setting. This is a diagnostic function performed outside of the body (in vitro).
- Device Description: The description confirms it's a test kit containing materials used for testing Heparin Anti-Xa activity.
- Intended User/Care Setting: It is intended for use in a "clinical laboratory setting by laboratory personnel," which is a typical environment for IVD testing.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VALIDATE® Heparin Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for Heparin Anti-Xa activity on automated instruments in a clinical laboratory setting by laboratory personnel. The product is intended for use on the IL ACL TOP® analyzer.
Product codes
GGN
Device Description
Each VALIDATE® Heparin Calibration Verification / Linearity Test Kit contains one analyte set of Heparin in a human plasma base matrix. The kit includes a set containing five liquid levels, 3.0 mL each. The set is provided to establish the relationship between theoretical and actual performance of Heparin Anti-X activity. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.
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
Laboratory personnel in a clinical laboratory setting.
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
Precision/Reproducibility: Precision was evaluated on the Instrumentation Laboratory (IL) IL ACL TOP 500® instrument system with the VALIDATE® Heparin product. Three lots of VALIDATE® Heparin product were tested with one lot of IL HemosIL® Liguid Anti-Xa reagent and quality controls on one IL ACL TOP 500® instrument system over 20 days, 2 runs per day, 2 replicates per run for Level 1 through Level 5 with a minimum of two operators to obtain a total of eighty (80) replicates per kit Level. All levels of the VALIDATE® Heparin kit met the CV% acceptance criteria. Reproducibility was evaluated on the IL ACL TOP 500® instrument system with one lot of VALIDATE® Heparin Calibration Verification / Linearity Test Kit tested with one lot of IL Heparin HemosIL® reagent and quality controls on three instruments, multi-site, over 5 days, with 1 run per day of Level 1-5, 5 replicates per run and a minimum of three operators to obtain seventy-five (75) replicates per kit level. All levels of the VALIDATE® Heparin kit met the CV% acceptance criteria.
Value Assignment: Typical recovery values for Level 1 and Level 5 were established by testing 30 replicates.
Stability: Stability testing on four product lots was performed using the IL ACL TOP 500® instrument system. A freeze-thaw/open vial stress stability assessment was also conducted.
Linearity: Linearity testing was carried out with the new device VALIDATE® Heparin Calibration Verification / Linearity Test Kits on the Instrumentation Laboratory IL ACL TOP 500® coagulation instrument.
Key Metrics
All levels of the VALIDATE® Heparin kit met the CV% acceptance criteria on the IL ACL TOP 500® instrument system.
Acceptance criteria for stability are defined as 90 to 110% of DOM value.
All product levels tested within the acceptance criteria limits after 2 freeze-thaw vial events.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
Maine Standards Company LLC Mr. James Champlin Director, QSHIE 221 US Route 1 Cumberland Foreside, Maine 04110
Re: K163498
Trade/Device Name: Validate® Heparin Calibration Verification/Linearity Test Kit Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: February 14, 2017 Received: February 15, 2017
Dear Mr. Champlin:
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
1
as set forth in the quality systems (OS) 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/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 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,
Leonthena R. Carrington -S
Lea 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) | K163498 |
|---|---|
| Device Name | VALIDATE® Heparin Calibration Verification / Linearity Test Kit |
| Indications for Use (Describe) | VALIDATE® Heparin Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for Heparin Anti-Xa activity on automated instruments in a clinical laboratory setting by laboratory personnel. The product is intended for use on the IL ACL TOP® analyzer. |
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
3
510(k) SUMMARY
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
The assigned 510(k) number is: K163498
A. Submitter: Maine Standards Company LLC 221 US Route 1 Cumberland Foreside, ME 04110 Telephone: 207-892-1300 Fax: 207-892-2266
Contact Person: James Champlin Director, QSHIE jchamplin@mainestandards.com Telephone: 207-892-1300 Ext. 29
Date of Summary Preparation: February 14, 2017
B. Device Classification:
| Device classification name: | Plasma, Coagulation Control |
|---|---|
| Common name: | Calibration Verification / Linearity Test Kit |
| Proprietary Name: | VALIDATE® Heparin Calibration Verification / Linearity Test |
| Kit | |
| Review Panel: | Hematology (81) |
| Regulation Number: | 21 CFR 864.5425 |
| Product Code: | GGN |
| Regulatory Class: | Class II |
C. Predicate Device Identification:
K090209, HemosIL® Liquid LMW/UF Heparin Controls, Instrumentation Laboratory
D. Candidate Device description: Each VALIDATE® Heparin Calibration Verification / Linearity Test Kit contains one analyte set of Heparin in a human plasma base matrix. The kit includes a set containing five liquid levels, 3.0 mL each. The set is provided to establish the relationship between theoretical and actual performance of Heparin Anti-X activity. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.
E. Intended use
VALIDATE® Heparin Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for Heparin Anti-Xa activity on automated instruments in a clinical laboratory setting by laboratory personnel. The product is intended for use on the IL ACL TOP 500® analyzer.
Page 5-1
4
F. Summary of Performance Data:
The performance of the new VALIDATE® Heparin Calibration Verification / Linearity Test Kit was compared to the predicate device k09209, HemosIL® Liquid LMW/UF Heparin Controls.
Table 1 summarizes the comparison of the new VALIDATE® Heparin Calibration Verification / Linearity Test Kit device to the predicate device.
| New Device
VALIDATE® Heparin Calibration
Verification / Linearity Test Kit | Predicate (k09209)
HemosIL® Liquid LMW/UF
Heparin Controls | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------|
| Similarities | | |
| Intended Use | For in vitro diagnostic use with
HemosIL® reagents on the IL
ACL TOP 500 instrument | Same |
| Test Kit | Assayed quality control | Same |
| Matrix | Human plasma base | Same |
| Number of Levels | 5 levels | Same |
| FDA product Code | GGN | Same |
| Differences | | |
| Analytes | Heparin Anti-Xa activity | LMW/UFH Heparin |
Table 1 - Comparison to Predicate
Value Assignment
VALIDATE® Heparin Calibration Verification / Linearity Test Kits are manufactured such that an equal relationship exists among Levels 1 through 5; Level 1 being the lowest concentration and Level 5 being the highest. Levels 1 and 5 are prepared independently by the addition of Heparin to a human plasma base matrix. Levels 1 through 5 must meet specified Heparin Anti-Xa target ranges at all stages of testing.
Specific recovery targets for Levels 1 through 5 are determined by the upper and lower detection limits for Heparin Anti-Xa. Intermediate Levels 2, 3, and 4 are subsequently prepared from Levels 1 and 5 by equal part dilutions following EP6-A guidelines. Typical value ranges are provided in the package insert.
Typical recovery values, presented in Table 2, were established for Level 1 and Level 5 by testing 30 replicates, with values for Mid-Levels 2, 3, and 4 calculated based on an equal distance (delta) between levels.
The product is designed for laboratories to satisfy the requirements for calibration verification and verification of the systems reportable range as specified in the current CLIA regulations section 493.1255.
5
| Set | ||||||||
|---|---|---|---|---|---|---|---|---|
| Levels | ||||||||
| Instrument | Analyte | Units | 1 | 2 | 3 | 4 | 5 | |
| IL ACL TOP 500® | Heparin | |||||||
| Anti-Xa | IU/mL | 0.11 | 0.52 | 0.94 | 1.36 | 1.77 |
A linear relationship exists between each level in a kit. The quantitative determination of linearity, calibration verification, and verification of reportable range relies on the known relationship between each of the levels of the product, in this case equal deltas, as outlined in the CLSI EP6-A referenced standard.
This kit is not intended for use as calibration material.
Precision/Reproducibility
Precision was evaluated on the Instrumentation Laboratory (IL) IL ACL TOP 500® instrument system with the VALIDATE® Heparin product following the product package insert instructions. Three lots of VALIDATE® Heparin product were tested with one lot of IL HemosIL® Liguid Anti-Xa reagent and quality controls on one IL ACL TOP 500® instrument system over 20 days. 2 runs per day. 2 replicates per run for Level 1 through Level 5 with a minimum of two operators to obtain a total of eighty (80) replicates per kit Level. All levels of the VALIDATE® Heparin kit met the CV% acceptance criteria on the IL ACL TOP 500® instrument system.
Reproducibility was evaluated on the IL ACL TOP 500® instrument system with the VALIDATE® Heparin kit containing 5 levels following the product package insert instructions. One lot of VALIDATE® Heparin Calibration Verification / Linearity Test Kit was tested with one lot of IL Heparin HemosIL® reagent and quality controls on three instruments, multi-site, over 5 days, with 1 run per day of Level 1-5, 5 replicates per run and a minimum of three operators to obtain seventy-five (75) replicates per kit level. All levels of the VALIDATE® Heparin kit met the CV% acceptance criteria on the IL ACL TOP 500® instrument system.
Traceability
This product is traceable to a reference standard based on the automated instrument platform it is used on. The traceability of this product will be established per the respective end user automated instrument method calibrator traceability reference statement. The VALIDATE® Heparin kit is traceable through the IL HemosIL® calibrator to the 5th International WHO Standard 97/578 for UF heparin and the 2nd International WHO Standard 01/608 for LMW heparin.
Stability
Stability testing on four product lots was performed using the IL ACL TOP 500® instrument system. The study testing time points included date of manufacture (DOM), followed by testing at specific intervals post manufacture. Acceptance criteria are defined as 90 to 110% of DOM value.
A freeze-thaw/open vial stress stability assessment was also conducted in support of the product package insert two (2) freeze-thaw open vial events claim. All product levels tested within the acceptance criteria limits after 2 freeze-thaw vial events.
6
Shelf Life Claim: Stability of the VALIDATE® Heparin Calibration / Linearity Test Kit was set at 5 months based on available real-time stability studies. Real time stability studies are ongoing to support an extended stability claim. The recommended storage temperature is -10 to -25°C. All supporting data is retained on file at Maine Standards Company LLC.
Linearity:
Linearity testing was carried out with the new device VALIDATE® Heparin Calibration Verification / Linearity Test Kits on the Instrumentation Laboratory IL ACL TOP 500® coagulation instrument. Product linearity performance was demonstrated for this automated system. All supporting data is retained on file at Maine Standards Company LLC.
G. Conclusion:
Based upon the purpose of the device, the descriptions and labeling of the predicate device, the VALIDATE® Heparin Calibration Verification / Linearity Test Kit behaves substantially equivalent to the predicate device, K090209, HemosIL® Liquid LMW/UF Heparin Controls.