(35 days)
Not Found
No
The summary describes a calibration verification test set for in vitro diagnostic use, which is a chemical reagent product. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML mentions.
No.
The device is for in vitro diagnostic use to verify calibration and linearity of chemistry systems for thyroid analytes, rather than for direct therapeutic intervention on a patient.
No
Explanation: This device is a calibration verification test set, meaning it is used to verify the proper functioning of chemistry systems that perform diagnostic tests. It is not a diagnostic device itself, but rather a tool used in the quality control of diagnostic testing.
No
The device is a calibration verification test set consisting of physical solutions (human serum based materials in bottles), not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use..."
This statement, along with the description of the device being used to verify the performance of chemistry systems for quantitative determination of analytes, clearly indicates its intended use in a laboratory setting for diagnostic purposes.
N/A
Intended Use / Indications for Use
VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.
Product codes (comma separated list FDA assigned to the subject device)
JJY, JJX
Device Description
Quality control material (assayed and unassayed)
VALIDATE Thyroid Calibration Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of six (6) levels including zero. Each bottle of Levels 0 through 5 contains 3.0 milliliters. There exists a linear relationship among each set of solutions.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company LLC. The logo is divided diagonally by a thick black line. The word "maine" is in the upper left corner, and the word "standards" is in the lower right corner. Below "standards" is the word "COMPANY LLC" in smaller letters.
SEP 2 9 2006
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: K062501."
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt Trail |
| Windham, ME 04062 | |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Holly A. Cressman, Mgr. QA/RA |
August 16, 2006 Summary prepared on:
| Device classification name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
|---|---|
| Device description: | Quality control material (assayed and unassayed) |
| Proprietary Name: | VALIDATE® Thyroid Calibration Verification Test Set |
| Regulation Number: | 21 CFR 862.1660 |
| Product Code: | JJY |
| Regulatory Class: | Class I |
Predicate Device:
DOCUMENT Thyroid CAL VER (K992034), Microgenics Corp, Fremont, CA
Device description: VALIDATE Thyroid Calibration Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of six (6) levels including zero. Each bottle of Levels 0 through 5 contains 3.0 milliliters. There exists a linear relationship among each set of solutions.
Intended use: The VALIDATE Thyroid Calibration Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the following analytes: Triodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol. VALIDATE Thyroid Calibration Verification Test Set solutions are not intended for use as routine quality control materials or as calibration materials.
Summarv:
The information provided in this pre-market notification demonstrates that the performance of VALIDATE Thyroid Calibration Test Sets is substantially equivalent in form and function to the predicate device for its stated intended use.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, services, and people. The department's name is written in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Holly Cressman, OA/RA Manager Maine Standards Company, LLC 765 Roosevelt Trail Windham, ME 04062
EP 2 9 2006
Re: K062501
Trade/Device Name: VALIDATE® Thyroid Calibration Verification Test Set Regulation Number. 21 CFR 862.1660 --Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: August 22, 2006 Received: August 25, 2006
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Guticirez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K 0 6 2 50 L
VALIDATE® Thyroid Calibration Verification Test Set Device Name:
Indications For Use:
VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR 807 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)
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device
Evaluation and Safety
K062501