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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Adequate recovery across all levels 1 through 5 must meet specified ferritin target ranges at all stages of testing.	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. (This is a restatement of the criteria, implying it was met but without numerical data provided.)
Stability acceptance criteria: 90 to 110% of DOM (Date of Manufacture) value for product levels 2-5 after testing at specific intervals post manufacture (up to one month post-expiration).	All product levels tested within the 90 to 110% of control/acceptance criteria limits.
Freeze/thaw stability acceptance criteria: 90 to 110% of control/acceptance criteria limits after specified freeze/thaw events.	All product levels tested within the 90 to 110% of control/acceptance criteria limits after 6 freeze/thaw events. (The claim in the IFU is for 4 freeze/thaw events, and the testing showed compliance for 6.)
Shelf Life Claim: Stability of 12 months based on real-time open vial studies.	Shelf life set at 12 months. (Implied that the real-time open vial studies supported this claim.)
Linearity performance: Demonstrated linearity for a specific duration for both automated systems tested.	Product linearity performance was demonstrated for 431 days (14 months) for both automated systems (Roche® Cobas 6000 Chemistry Analyzer and Beckman-Coulter® Access II Immunochemistry Analyzer).

Device Study Information:

Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated as a numerical sample size in terms of unique patient samples. The "test set" in this context refers to the five liquid levels (0.5 to 2000 ng/mL typical values) of the VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit itself. These levels are tested on different instruments and over time.
- Data Provenance: The study was conducted by Maine Standards Company LLC. It involved stability testing (real-time and freeze/thaw) and linearity testing using representative instruments (Beckman Coulter Access II and Roche COBAS 6000). The materials are "purified chemicals in a human serum base." The exact country of origin for the human serum base is not specified, but the submitter is a US company (Maine Standards Company LLC, Cumberland Foreside, ME). The studies appear to be prospective as they involved testing at specific intervals post-manufacture and over a period of 431 days for linearity.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a quality control material and calibration verification kit. Its "ground truth" is established by the known concentrations of ferritin in each of the five levels, manufactured to have an "equal relationship" among them. Expert adjudication of individual results is not part of this type of study. The concentrations are determined by the manufacturing process and validated against instrument performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as expert adjudication is not relevant for this type of device. The performance is assessed against predefined statistical criteria (e.g., 90-110% recovery) based on the known values of the control material.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in-vitro diagnostic quality control product, not an AI-assisted diagnostic tool that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical calibration verificaion/linearity solution, not a software algorithm. Its performance is evaluated on automated instrument systems directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on pre-defined, manufactured concentrations of ferritin in the different levels of the kit. Level 1 and 5 are "prepared independently by the addition of ferritin to a human serum base," and intermediate levels (2, 3, 4) are prepared by equal part dilutions. The "known relationship between each of the levels of the product (in this case equal deltas as outlined in the CLSI EP6A referenced standard)" serves as the basis for evaluating linearity and calibration verification.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set." The product is manufactured to specific specifications.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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K133550

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 / LinearityTest 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 DeviceVALIDATE® FERRITIN	Predicate (K013119)VALIDATE® Chem 6
	Calibration Verification / LinearityTest Kit	Calibration Verification / Linearity TestKit
	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 thequantitative determination oflinearity, calibration verificationand verification of reportablerange in automated instrumentsystems	For in vitro diagnostic use in thequantitative determination of linearity,calibration verification and verificationof reportable range in automated,semi-automated and manualinstrument 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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

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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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Regulation Number and Section

§ 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.