(78 days)
No
The summary describes a calibration verification/linearity test kit for ferritin, which is a chemical reagent kit used for quality control on automated instrument systems. There is no mention of any computational algorithms, image processing, or data analysis that would suggest the use of AI or ML. The performance studies focus on stability and linearity testing of the reagent kit itself.
No.
Explanation: The device is a "Calibration Verification / Linearity Test Kit" for in vitro diagnostic use, meaning it's used to verify the accuracy and linearity of automated instrument systems that measure ferritin levels. It is not used to treat, diagnose, or cure a disease in a patient.
Yes
The "Intended Use / Indications for Use" section states that the solutions are "intended for in vitro diagnostic use." The "Device Description" also mentions its use in the "quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte, ferntin, on automated instrument systems," which are steps in the diagnostic process.
No
The device is a test kit containing physical solutions and chemicals, 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".
- Device Description: The description details that the kit contains materials used to "establish the relationship between theoretical and actual performance" for the analyte ferritin on automated instrument systems. This is a function performed in a laboratory setting to verify the accuracy of diagnostic tests.
- Analyte: The device is used to verify the measurement of "ferritin", which is a substance measured in biological samples (human serum) for diagnostic purposes.
- Use with Quantitative Assays: The intended use specifies it's for use with "quantitative assays on the indicated analyzers", which are diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
N/A
Intended Use / Indications for Use
VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte, ferntin, on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.
Product codes
JJX
Device Description
Each VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit contains purfied chemicals in a human serum base. Five Iliguit Invelos, 3.0mL each, ranging from 0.5.to.2000 ng/mL typical values, are provided to establish the relationship between theoretical and actual performance of the included analyte ferritin. 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
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Intended User / Care Setting
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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
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Summary of Performance Studies
The performance of the new VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit was compared to the predicate device K013119 VALIDATE® Chem 6 Calibration Verification / Linearity Test Kit.
Stability testing was performed using Beckman Coulter Access II and Roche COBAS 6000 instrument systems. The study testing time points included date of manufacture (DOM), followed by testing at specific intervals post manufacture. The last testing event is one month post-expiration. Acceptance criteria are defined as 90 to 110% of DOM value for product levels 2-5.
A freezelthaw stability assessment was also conducted in support of the product package insert (IFU) four (4) freeze/thaw events claim. All product levels tested within the 90 to 110% of controllacceptance criteria limits after 6 freeze/thaw events.
Linearity testing was carried out on DOM through Day 431 with the candidate device VALIDATE® FERRITIN. Calibration Verification / Lineanty Test Kits using a Roche® Cobas 6000 Chemistry Analyzer and Beckman-Coulter® Access II Immunochemistry Analyzer (instrument of manufacture). Product linearity performance was demonstrated for 431 days (14 months) for both automated systems.
Key Metrics
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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FEB - 5 2014
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: K133550.
A. Submitter:
Maine Standards Company LLC 221 US Route 1 Cumberland Foreside, ME 04110 Telephone: 207-892-1300 207-892-2266 Fax:
Contact Person:
James Champlin Manager, Quality Assurance & Regulatory Affairs Telephone: 207-892-1300 Ext. 29
Date of Summary Preparation: December 6, 2013
B. Device Classification:
| Device classification name: | Quality control material (assayed and un-assayed)* |
|---|---|
| Common name: | Calibration Verification / Linearity Test Kit |
| Proprietary Name: | VALIDATE® FERRITIN Calibration Verification / Linearity |
| Test Kit | |
| Review Panel: | Clinical Chemistry |
| Regulation Number: | 21 CFR 862.1660 |
| Product Code: | JJX* |
*Note: There is no FDA product code for calibration / linearity materials. Therefore, as with previous submissions by Maine Standards Company and other calibration vertfication / linearity manufacturers, JJX was selected as the "best fit" FDA code for this product. Regulatory Class:
Class !
C. Predicate Device Identification:
VALIDATE® Chem 6:Calibration Verification / Linearity Test Kit Maine Standards Company LLC, Cumberland Foreside, ME 04110. 510(k) Number: K013119
D. Candidate Device description: Each VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit contains purfied chemicals in a human serum base. Five Iliguit Invelos, 3.0mL each, ranging from 0.5.to.2000 ng/mL typical values, are provided to establish the relationship between theoretical and actual performance of the included analyte ferritin. 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® FERRITIN Calibration Verfication / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte, ferntin, on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.
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F. Summary of Performance Data:
The performance of the new VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit was compared to the predicate device K013119 VALIDATE® Chem 6 Calibration Verification / Linearity Test Kit. Table 1 compares the technical characteristics of the new VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit with those of the predicate VALIDATE® Chem 6 Calibration Verification / Linearity Test Kit.
| | New Device
VALIDATE® FERRITIN | Predicate (K013119)
VALIDATE® Chem 6 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Calibration Verification / Linearity
Test Kit | Calibration Verification / Linearity Test
Kit |
| | Similarities | |
| Test Kit | Calibration Verification Test Kit | Same |
| Number of analytes | One analyte | One analyte |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Stability | Until expiration date | Until expiration date |
| | Differences | |
| Intended Use | For in vitro diagnostic use in the
quantitative determination of
linearity, calibration verification
and verification of reportable
range in automated instrument
systems | For in vitro diagnostic use in the
quantitative determination of linearity,
calibration verification and verification
of reportable range in automated,
semi-automated and manual
instrument systems |
| Matrix | Human serum base | Aqueous |
| Number of Levels | 5 levels | 5 levels plus a level zero |
| Analytes | Ferritin | Uric Acid |
| Packaging | 3.0 mL each level | 5.0 mL each level |
| Storage | -10 to -25°C | 2 to 8°C |
Table 1 - Technical Comparison to Predicate
Value Assignment
VALIDATE® FERRITIN Calibration / Linearity Test Kits are manufactured such that a 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 ferritin to a human serum base. Specific recovery targets for Levels 1 and 5 are determined by the upper and lower detection limits for the intended analyzers. 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 value ranges for the each level of the linearity set on representative Roche Cobas 6000 and Beckman Access instruments are summanized in the table below ..
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The VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit is tested on an analyzer to confirm adequate recovery across all levels 1 through 5 must meet specified ferritin target ranges at all stages of testing.
The quantitative determination of linearity, calibration, 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 EP6A referenced standard) not on an expected value. As such, the product use is not limited to a particular instrument Expected target values may change depending on instrumentation, system. methodology, and assay temperature
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Traceability
This product is traceable to a reference standard based on the automated instrument platform it is used on. The traceablity of our product will be established per the respective end user automated instrument calibrator traceability reference statement.
Stability
Stability testing was performed using Beckman Coulter Access II and Roche COBAS 6000 instrument systems. The study testing time points included date of manufacture (DOM), followed by testing at specific intervals post manufacture. The last testing event is one month post-expiration. Acceptance criteria are defined as 90 to 110% of DOM value for product levels 2-5.
A freezelthaw stability assessment was also conducted in support of the product package insert (IFU) four (4) freeze/thaw events claim. All product levels tested within the 90 to 110% of controllacceptance criteria limits after 6 freeze/thaw events.
Shelf Life Claim: Stability of the VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit was set at 12 months based on real-time open vial studies as a worst case scenano. 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 on DOM through Day 431 with the candidate device VALIDATE® FERRITIN. Calibration Verification / Lineanty Test Kits using a Roche® Cobas 6000 Chemistry Analyzer and Beckman-Coulter® Access II Immunochemistry Analyzer (instrument of manufacture). Product linearity performance was demonstrated for 431 days (14 months) for both automated systems. 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 FERRITIN Calibration Verfication / Linearity Test Kit behaves substantially equivalent to the predicate for the evaluation of calibration verification. verification of reportable range. The product is substantially equivalent to the predicate device K013119.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2014
MAINE STANDARDS COMPANY LLC JAMES CHAMPLIN MANAGER, QA AND RA 221 US ROUTE 1 CUMBERLAND FORESIDE ME 04110
Re: K133550
Trade/Device Name: VALIDATE FERRITIN Calibration Verification/ Linearity Test Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: December 19, 2013 Received: January 7, 2014
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 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.
4
Page 2-Mr. Champlin
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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, plaaress the regulation entitled; "Misbranding by reference to premarket notification" (21CFF). Past 807.97). For questions regarding the reporting of adverse events under the MDR ogglation (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.
Courtney H. Lias -S
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133550
Device Name
VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit
Indications for Use (Describe)
VALIDATE® FERRITIN Calibration / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range for the following analyte, ferritin, on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FDA USE ONLY - B + 4 4 4 4 4 4 4 4 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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