(84 days)
Not Found
No
The document describes a quality control product for laboratory testing and makes no mention of AI or ML.
No.
The device is described as an "assayed control serum to monitor the precision of laboratory testing procedures," indicating it is used for quality control in diagnostics, not for treating patients.
No
The device is described as an "assayed control serum to monitor the precision of laboratory testing procedures" for Vitamin D, and a "quality control product" to assess "good laboratory practices." It is used to ensure consistent performance of a testing system, not to directly diagnose a patient's condition.
No
The device is a quality control product described as a "control serum," indicating it is a physical substance used for laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the precision of laboratory testing procedures for the analysis of Vitamin D." This involves testing samples in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: It describes the product as a "quality control product" used to "assess good laboratory practices" and "assuring consistent performance of the testing system within the clinical range." This is a core function of IVD quality control materials.
- Intended User / Care Setting: It specifies "Clinical and Hospital laboratories," which are typical settings where IVD testing is performed.
- Predicate Device: The presence of a predicate device (K043108; Bio-Rad Liquichek" Specialty Immunoassay Control - 25-OH Vitamin D component) which is also a control material for Vitamin D testing, further supports its classification as an IVD.
While the document doesn't mention image processing, AI, or specific performance metrics, the core function and intended use align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
JJX
Device Description
Not Found
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
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
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)
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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Premarket Notification (510(k)) Tumor Marker Control
Image /page/0/Picture/1 description: The image shows the date "MAY 27 2011" on the left side. On the right side, there is a handwritten "K110641". Below the date, there is a logo for "FUJIREBIO Diagnostics, Inc.". The logo includes a stylized graphic element to the left of the text.
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:
Submitter Information
Address:
Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
- Stacey Dolan Contact person: (610) 240-3843 dolans@fdi.com
Summary preparation date: March 2, 2011
Name of Device
| Trade/Proprietary Name: | Fujirebio Diagnostics Vitamin D Control |
|---|---|
| ------------------------- | ----------------------------------------- |
Common/Usual Name: Quality control material (assayed and unassayed).
21 CFR 862.1660 Regulation Number:
Regulatory Class: Class |
JJX Product Code:
Predicate Device
Bio-Rad Liquichek" Specialty Immunoassay Control (K043108) - 25-OH Vitamin D component
Summary and Principle
This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Three levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.
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.
1
Image /page/1/Picture/1 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic on the left, followed by the company name in bold, black letters. Below the company name, the words "Diagnostics, Inc." are printed in a smaller, non-bold font.
Statement of Substantial Equivalence
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 Fujirebio Diagnostics Vitamin D Control is substantially equivalent to the 25-OH Vitamin D
component of the Bio-Rad Liquichek" Specialty Immunoassay Control. Both of the quality control serum and are used to monitor the precision of laboratory testing procedures for Vitamin D.
The regulatory submission is prepared pursuant to Title 21CFR § 862.1660.
A comparison of the features of the Fujirebio Diagnostics Vitamin D Control and the 25-0H Vitamin D component of Bio-Rad Liquichek" Specialty Immunoassay Control are as follows:
| Similarities | ||
|---|---|---|
| Fujirebio Diagnostics Vitamin D | ||
| Control | ||
| (Proposed Device) | Bio-Rad Liquichek™ Specialty | |
| Immunoassay Control - 25-OH | ||
| Vitamin D | ||
| (Predicate Device) | ||
| K043108 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class I | Class I |
| CFR section | 862.1660 | 862.1660 |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | The 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. | Liquichek Specialty Immunoassay | |
| Control is intended for use as a | ||
| quality control serum to monitor | ||
| the precision of laboratory testing | ||
| procedures for the analytes listed | ||
| in the package insert. | ||
| 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. | Human Serum with added | |
| constituents of human and animal | ||
| origin, chemicals, stabilizers and | ||
| preservatives. | ||
| Number of Levels | 3 | 3 |
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:
Image /page/2/Picture/1 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic on the left, followed by the company name in bold, black letters. Below the company name, the words "Diagnostics, Inc." are written in a smaller font size.
| Differences | ||
|---|---|---|
| Fujirebio Diagnostics Vitamin | ||
| D Control | ||
| (Proposed Device) | Bio-Rad Liquichek™ Specialty | |
| Immunoassay Control - 25-OH | ||
| Vitamin D | ||
| (Predicate Device) | ||
| K043108 | ||
| Reconstitution Volume | 2.0 mLs | 5.0 mLs |
| Vitamin D | ||
| Analyte Forms | 25(OH) Vitamin D2 | |
| 25(OH) Vitamin D3 | 25(OH) Vitamin D3 | |
| Other Analytes | Contains only 25(OH) Vitamin D | Contains also: |
| Anti-Tg | ||
| Anti-TPO | ||
| C-peptide | ||
| Erythropoietin (EPO) | ||
| Intact PTH (iPTH) | ||
| IGF-I | ||
| Osteocalcin | ||
| Storage (unopened) | 12 months at 2 to 8°C | 2 years at -20°C to -70°C |
| Form | Lyophilized | Liquid |
| Product Code | JJX | JJY |
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Fujirebio Diagnostics, Inc. c/o Ms. Stacey Dolan Manager, Regulatory Affairs 201 Great Valley Parkway Malvern, PA 19355
MAY 2 7 2011
K110641 Trade Name: Fujirebio Diagnostics Vitamin D Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: March 03, 2011 Received: March 04, 2011
Dear Ms. Dolan:
Re:
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 Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (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/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Fujirebio Diagnostics Vitamin D Control
Indications for 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.
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 OF 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) K110641
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