K Number
K113524
Device Name
VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
Date Cleared
2012-01-27

(59 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VALIDATE® VIT D Calibration Verification / 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: total 25 (OH) vitamin D (VIT D).
Device Description
Each VALIDATE® VIT D Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
More Information

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No
The summary describes a calibration and linearity test kit for in vitro diagnostic use, which is a chemical-based product for verifying the performance of analytical instruments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

No
This device is an in vitro diagnostic (IVD) test kit used for calibration and verification of laboratory instruments, not for direct therapeutic treatment of a patient.

No
This device is a calibration and linearity test kit used to verify the performance of other in vitro diagnostic devices that measure total 25 (OH) vitamin D. It is not used to directly diagnose a patient's condition.

No

The device description explicitly states that the kit contains "purified chemicals in a human serum base," indicating it is a physical kit with reagents, not a software-only device.

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 solutions are "intended for in vitro diagnostic use".
  • Purpose: The purpose of the kit is for the "quantitative determination of linearity, calibration and verification of reportable range" for total 25 (OH) vitamin D. This is a diagnostic process performed outside of the body (in vitro) to assess the performance of a diagnostic test for a specific analyte.
  • Device Description: The description mentions the kit contains "purified chemicals in a human serum base," which are components used in laboratory testing.

All these points align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

VALIDATE® VIT D Calibration Verification / 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: total 25 (OH) vitamin D (VIT D).

Product codes

JJX

Device Description

Each VALIDATE® VIT D Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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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

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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)

The VALIDATE® VIT D Calibration Verification / Linearity Test Kit behave in a manner suitable for the evaluation of calibration, verification of reportable range, and the linear response of the listed analytes over the ranges tested when compared to the predicate device. VALIDATE® VIT D Calibration Verification / Linearity Test Kit is as safe and effective as the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

VALIDATE® Chem 6 Calibration Verification / Linearity Test Kit

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company. The logo has the word "maine" on the top left and the word "standards" on the bottom right. There is a line going through the middle of the two words. Below the word "standards" is the word "COMPANY".

JAN 2 7 2012

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 (~1 |

Submitter:Maine Standards Company
Address:765 Roosevelt Trail
Windham, ME 04062

Telephone: 207-892-1300 Fax: 207-892-2266

Contact: Holly Cressman

Summary prepared on: November 15, 2011

Device classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassaved) Device description: Quality control material (assayed and un-assayed)*

Proprietary Name: VALIDATE® VIT D Calibration Verification / Linearity Test Kit

Requiation Number: 21 CFR 862.1660

Product Code: JJX*

*Note: There is no FDA product code for calibration verification / linearity materials. Therefore, as with previous submissions by Maine Standards Company and other calibration verfication / lineanty manufacturers, JJX was selected as the "best fir" FDA code for this product.

Regulatory Class: Class I

Predicate Device:

VALIDATE® Chem 6 Calibration Verification / Linearity Test Kit, Maine Standards Company, Windham, ME.

Device description: Each VALIDATE® VIT D Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

Intended use: VALIDATE® VIT D Calibration Verification / 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: total 25 (OH) vitamin D (VIT D).

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The VALIDATE® VIT D Calibration Verification / Linearity Test Kit behave in a manner suitable for the evaluation of calibration, verification of reportable range, and the linear response of the listed analytes over the ranges tested when compared to the predicate device. VALIDATE® VIT D Calibration Verification / Linearity Test Kit is as safe and effective as the predicate device.

.

.

. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Maine Standards Company, LLC c/o Holly A. Cressman 765 Roosevelt Trail Windham, ME 04062

JAN 2 7 2012

K113524 Re:

Trade Name: VALIDATE® VIT D Calibration Verification / Linearity Test Kit Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: January 11, 2012 Received: January 18, 2012

Dear Ms. Cressman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal 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 or medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 proase note the rogalation regarding postmarket surveillance, please contact CDRH's CITY at 607.977. For quebalom etrig's (OSB's) Division of Postmarket Surveillance at (301) Office of bur vinalio and said on the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely vours.

signature

Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

K 11 3524 510(k) Number:

Device Name: VALIDATE® VIT D Calibration Verification / Linearity Test Kit

Indications For Use:

VALIDATE® VIT D Calibration Verification / 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: total 25 (OH) Vitamin D (VIT D).

Prescription Use × (Part 21 CFR 801 Subpart D)

.............................................................................................................................................................................. ... ...

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rute C. heeler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_K (1352-

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