(195 days)
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No
The 510(k) summary describes a quality control product for laboratory procedures, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is a quality control product for laboratory procedures, not a device used to treat patients.
No
Explanation: This device is a quality control product used to assess the performance of laboratory procedures for quantitating Total 25-OH Vitamin D. It is not used to diagnose a disease or condition in a patient, but rather to ensure the accuracy of diagnostic tests.
No
The device description clearly indicates a "quality control product" which is a physical substance used in laboratory procedures, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D." This means it's used in a laboratory setting to evaluate the performance of tests that measure a substance (Vitamin D) in a sample taken from the human body.
- Device Description: The description reinforces this by stating it's a "quality control product" intended for "objective measurement of a laboratories performance."
- Intended User / Care Setting: It specifies "Clinical and Hospital Laboratories," which are typical settings where IVD tests are performed.
- Predicate Device: The mention of a predicate device (K110641; Fujirebio Diagnostics Vitamin D Control) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
In summary, the device is designed to be used in a laboratory to assess the accuracy and reliability of tests performed on human samples, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantimetrix Complete D® 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
Product codes
JJX
Device Description
This quality control product is intended to allow an objective measurement of a laboratories performance (procedures and personnel techniques) in comparison to known values. Two clinically relevant levels of controls are available to compare observations with expected ranges therefore assuring consistent performance.
The Quantimetrix control product employs a similar human serum matrix and constituent formulation to the equivalent predicate device listed above. The serum matrix is fortified with reagent grade chemicals as well as preservatives. The Quantimetrix Control also has similar storage and stability requirements as the equivalent device.
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
Clinical and Hospital Laboratories
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
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Key Metrics
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Predicate Device(s)
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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510K Summary
Prepared: May 07, 2012
Submitted by: Quantimetrix Corporation
Establishment Address:
Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach CA 90278 Phone: 310/536-0006 FAX: 310/536-9977
. MAY 1 0 2012
Establishment Registration Number: 2020715 Contact Person: Kalyna Snylyk, Director of Quality Assurance & Regulatory Affairs Proprietary Name: Complete D® 25-OH Vitamin D Control Common Name: Vitamin D Control Classification Name: Single (Specified) Analyte Controls (Assayed and Unassayed) Product Code: JJX
Predicate Device:
Fujirebio Diagnostics Vitamin D Control (K110641)
Summary and Principle:
This quality control product is intended to allow an objective measurement of a laboratories performance (procedures and personnel techniques) in comparison to known values. Two clinically relevant levels of controls are available to compare observations with expected ranges therefore assuring consistent performance.
Intended Use:
The Quantimetrix Complete D 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
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Statement of Substantial Equivalence:
The Quantimetrix Complete D 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
The Quantimetrix Complete D 25-OH Vitamin D Control is substantially equivalent to the Fujirebio Diagnostics Vitamin D Control. Both of the devices are quality control serum and are intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
The regulatory submission is prepared pursuant to Title 21 CFR § 862.1660.
A comparison of the features of the Quantimetrix Complete D 25-0H Vitamin D Control and the Fujirebio Diagnostics Vitamin D Control are as follows:
| Similarities | ||
|---|---|---|
| Predicate Device | New product | |
| Control Name | Fujirebio Diagnositics, | |
| Inc.'s Vitamin D Control | Complete D 25-OH | |
| Vitamin D Control | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| 510K Class | 1 | 1 |
| CFR Section | 862.1660 | 862.1660 |
| Product Usage | Clinical and Hospital | |
| Laboratories | Clinical and Hospital | |
| Laboratories | ||
| Intended Use | Fujirebio Diagnostics | |
| Vitamin D Control is | ||
| intended for use as an | ||
| assayed control serum to | ||
| monitor the precision of | ||
| laboratory testing | ||
| procedures for the | ||
| analysis of Vitamin D. | The Quantimetrix | |
| Complete D Control is | ||
| intended for the quality | ||
| control of laboratory | ||
| procedures used to | ||
| quantitate 25- | ||
| Hydroxyvitamin D | ||
| Analyte | 25-OH Vitamin D | 25-OH Vitamin D |
| Matrix | Human serum, protein | |
| (bovine), purified | ||
| biochemical materials, | ||
| and chemicals. Proclin | ||
| 300 and Gentamicin as | ||
| preservatives. | Vitamin D depleted | |
| human serum, reagent | ||
| grade chemicals and | ||
| preservatives. | ||
| Number of Levels | 3 | 2 |
2
| Differences | ||
|---|---|---|
| Predicate Device | New product | |
| Fujirebio Diagnositics, | ||
| Inc.'s Vitamin D Control | Complete D 25-OH | |
| Vitamin D Control | ||
| Volume | 2.0mLs (reconstituted) | 3mLs. |
| Storage | ||
| (unopened) | 12 months at 2 to 8° C | 24 months at 2 to 8° C |
| Form | Lyophylized | Liquid |
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Technological Characteristics Compared to Predicate Devices (as required per Title 21 Sec 807.92).
The Quantimetrix control product employs a similar human serum matrix and constituent formulation to the equivalent predicate device listed above. The serum matrix is fortified with reagent grade chemicals as well as preservatives. The Quantimetrix Control also has similar storage and stability requirements as the equivalent device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
10903 New Hampshire Avenue Silver Spring, MD 20993
Quantimetrix Corp. c/o Kalyna Snylyk 2005 Manhattan Beach Blvd Redondo Beach, CA 90278-1205
MAY 1 0 2012
Re: K113177
Trade Name: Quantimetrix Complete D 25-OH Vitamin D Control Regulation Number: 21 CFR 8862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: April 19, 2012 Received: April 23, 2012
Dear Kalyna Snylyk:
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); medical device reporting (reporting of 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 contact the Office 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 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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 Division 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 yours,
Counney 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 Form.
510(k) Number (if known):
Complete D® 25-OH Vitamin D Control Device Name:
Indications for Use:
The Quantimetrix Complete D® 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
Prescription Use X (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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) |>
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