(98 days)
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
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. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.
This document describes the Fujirebio Diagnostics Tumor Marker Control, a quality control product intended to monitor the precision of laboratory testing procedures for various tumor markers. It is a Class I, reserved medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's performance as a control material. Instead, its performance is measured by its equivalence to a predicate device in terms of intended use, analytes, matrix, form, and stability. The performance is reported by comparing its features and characteristics to those of the predicate devices.
| Feature / Criterion | Fujirebio Diagnostics Tumor Marker Control (Proposed Device) | Bio-Rad Lyphochek® Tumor Marker Plus Control (Predicate) / ARCHITECT HE4 Control Kit (Predicate for HE4) |
|---|---|---|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class I, reserved | Class I, reserved |
| CFR section | 862.1660 | 862.1660 |
| Product Code | JJY | JJY |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | Assayed control serum to monitor the precision of laboratory testing procedures for AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA. | Assayed quality control serum to monitor precision for analytes listed in package insert (Lyphochek). Verification of accuracy and precision for ARCHITECT i System (HE4). |
| Matrix | Human Serum | Human Serum (Lyphochek); Protein buffer (ARCHITECT HE4) |
| Form | Lyophilized | Lyophilized (Lyphochek); Liquid (ARCHITECT HE4) |
| Analytes | AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, HE4, PSA, Free PSA | AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, PSA, Free PSA (Lyphochek); HE4 (ARCHITECT HE4) |
| Stability - Reconstituted at 2-8°C | 14 days at 2-8°C, except Free PSA (7 days) | 14 days at 2-8°C, except Free PSA (7 days) |
| Number of Levels | 2 | 3 |
| PSA Stability (reconstituted) | Total PSA - 14 days, Free PSA - 7 days | Total PSA – 7 days, Free PSA - 7 days |
| Reconstitution Volume | 3.0 mLs | 2.0 mLs |
| Additional Analytes | HE4 (Human Epididymis Protein 4) | ACTH, Aldosterone, Beta-2-Microglobulin, CA 27.29, Calcitonin, hCG, Prolactin, Prostatic Acid Phosphatase, and Thyroglobulin (Lyphochek) |
| Stability (unopened) | 18 months at 2-8°C | 3 years at 2-8°C (Lyphochek); 9 Months (ARCHITECT HE4) |
| Stability - Reconstituted at 2-8°C | CEA and Total PSA 14 days at 2-8°C | CEA 11 days at 2-8°C, Total PSA 7 days at 2-8°C |
| Stability - Reconstituted at <-20°C | All analytes are stable for 60 days when stored at <-20°C | All analytes are stable for 30 days when stored at <-20°C |
| Stability - Freeze/thaw | May be frozen and thawed repeatedly for up to 9 cycles | No claim made for freeze/thaw stability |
| Endogenous (Non-Spiked) analytes | CA 242 and CA 27.29* | None |
The acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate devices. The study provided is a comparative analysis demonstrating that the proposed device is substantially equivalent to the predicate devices despite some differences in specific characteristics, which are deemed not to raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance:
The document does not detail a specific "test set" in the context of patient samples or data. This is a quality control material, not a diagnostic test for patient samples. The "test set" implicitly refers to the control material itself, which was likely tested by the manufacturer to establish its stability, assigned values, and other characteristics compared to the predicate device.
Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing of the control material (manufacturer's data). The country of origin of the data is not specified but would likely relate to the manufacturer's testing facilities (Fujirebio Diagnostics, Inc., Malvern, PA, USA and Fujirebio Diagnostics, AB, Gothenburg, Sweden). It would be prospective in nature, as the control material itself would be tested according to a protocol.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable in this context. The "ground truth" for a quality control material is typically established through rigorous analytical testing to determine its assigned values and stability characteristics, often referencing established reference methods or certified reference materials, not through expert consensus in a clinical diagnostic sense. The document does not specify experts involved in establishing these analytical truths.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical studies where expert consensus is required for classification or diagnosis, which is not the case for a quality control material's analytical characterization.
5. 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 a quality control material, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for a quality control material like this involves:
- Assigned Values: Established through multiple analyses using validated methods, potentially referencing international standards or reference materials for the specific analytes.
- Stability data: Determined by conducting real-time and accelerated stability studies of the product under various conditions.
- Matrix comparability: Demonstrated through analytical testing to ensure the control matrix behaves similarly to clinical samples in assays.
The document implies that these analytical ground truths were established through standard laboratory practices for quality control manufacturing but does not detail the specific methodologies or reference standards used.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is used for this device.
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Image /page/0/Picture/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc.". The logo consists of a stylized graphic on the left, followed by the company name in a clear, sans-serif font. The word "FUJIREBIO" is on the top line, and "Diagnostics, Inc." is on the line below.
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: K101809
Submitter Information
OCT - 5 2010
| Address: | |
|---|---|
| ---------- | -- |
| Address: | Fujirebio Diagnostics, Inc.201 Great Valley ParkwayMalvern, PA 19355 |
|---|---|
| Contact person: | Stacey Dolan(610) 240-3843dolans@fdi.com |
| Summary preparation date: | October 5, 2010 |
Name of Device
| Trade/Proprietary Name: | Fujirebio Diagnostics Tumor Marker Control |
|---|---|
| Common/Usual Name: | Quality control material (assayed and unassayed). |
| Regulation Number: | 21 CFR 862.1660 |
| Regulatory Class: | Class I, reserved |
| Product Code: | JJY |
Fujirebio Diagnostics, Inc.
Predicate Device
Bio-Rad Lyphochek® Tumor Marker Plus Control (K082036) For HE4: ARCHITECT HE4 Control Kit (K093957)
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. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.
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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 and the company name on the right. The graphic is a geometric shape with a combination of solid and patterned areas. The text "FUJIREBIO" is in a bold, outlined font, and below it, "Diagnostics, Inc." is in a smaller, regular font.
Intended Use
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
Statement of Substantial Equivalence
The Fujirebio Diagnostics Tumor Marker Control is intended for use as a quantitative, assayed control serum to monitor the procedures used in the laboratory for testing the analytes listed in the lot specific assigned values sheet.
The Fujirebio Diagnostics Tumor Marker Control is substantially equivalent to the Lyphochek Tumor Marker Plus Control*. Each of the devices are assayed quality control material and are used to monitor the precision of laboratory testing procedures for the analytes listed in their respective package insert.
*Note: For HE4, the Fujirebio Diagnostics Tumor Marker Control is substantially equivalent to the ARCHITECT HE4 Control Kit.
The regulatory submission is prepared pursuant to Title 21CFR § 862.1660.
A comparison of the features of the Fujirebio Diagnostics Tumor Marker Control and the Predicate Device are as follows:
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| Similarities | ||
|---|---|---|
| Fujirebio Diagnostics TumorMarker Control(Proposed Device)K101809 | Bio-Rad Lyphochek® TumorMarker Plus Control(Predicate Device)K082036For HE4:ARCHITECT HE4 Control KitK093957 | |
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class I, reserved | Class I, reserved |
| CFR section | 862.1660 | 862.1660 |
| Product Code | JJY | JJY |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | For In Vitro Diagnostic Use Only.Fujirebio Diagnostics TumorMarker Control is intended for useas an assayed control serum tomonitor the precision of laboratorytesting procedures for the analysisof AFP, CA15-3, CA19-9, CA125,CEA, Ferritin, HE4, PSA and FreePSA. | Lyphochek Tumor Marker PlusControl is intended for use as anassayed quality control serum tomonitor the precision of laboratorytesting procedures for the analyteslisted in the package insert.The ARCHITECT HE4 Controlsare used for the verification of theaccuracy and precision of theARCHITECT i System when usedfor the quantitative determinationof HE4 antigen in human serum. |
| Matrix | Human Serum | Human Serum(For HE4, matrix is protein buffer) |
| Form | Lyophilized | Lyophilized(For HE4, Liquid) |
| Analytes | AFP, CA 15-3, CA 19-9, CA 125,CEA, Ferritin, PSA, Free PSA | AFP, CA 15-3, CA 19-9, CA 125,CEA, Ferritin, PSA, Free PSA |
| Stability - Reconstitutedat 2-8°C | 14 days at 2-8°C, except Free PSAwhich is stable for 7 days | 14 days at 2-8°C, except Free PSAwhich is stable for 7 days |
3 .
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Premarket Notification (510(k)) Tumor Marker Control
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| Differences | ||
|---|---|---|
| Fujirebio Diagnostics TumorMarker Control(Proposed Device)K101809 | Bio-Rad Lyphochek® TumorMarker Plus Control(Predicate Device)K082036For HE4:ARCHITECT HE4 Control KitK093957 | |
| Number of Levels | 2 | 3 |
| PSA Stability(reconstituted) | Total PSA - 14 daysFree PSA - 7 days | Total PSA – 7 daysFree PSA - 7 days |
| Reconstitution Volume | 3.0 mLs | 2.0 mLs |
| Analytes | HE4 (Human Epididymis Protein 4) | ACTH, Aldosterone, Beta-2-Microglobulin, CA 27.29,Calcitonin, hCG, Prolactin,Prostatic Acid Phosphatase, andThyroglobulin |
| Stability (unopened) | 18 months at 2-8°C | 3 years at 2-8°C(For HE4, 9 Months) |
| Stability - Reconstitutedat 2-8°C | CEA and Total PSA 14 days at2-8°C | CEA 11 days at 2-8°CTotal PSA 7 days at 2-8°C |
| Stability - Reconstitutedat <-20°C | All analytes are stable for 60 dayswhen stored at <-20°C | All analytes are stable for 30 dayswhen stored at <-20°C |
| Stability - Freeze/thaw | May be frozen and thawedrepeatedly for up to 9 cycles | No claim made for freeze/thawstability |
| Endogenous (Non-Spiked) analytes | CA 242 and CA 27.29* | None |
r
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Fujirebio Diagnostics, AB c/o Ms. Christina Hall Director, Quality and Regulatory Affairs Majnabbe Terminal Gothenburg, Sweden, SE 41455, SW
OCT 05 2010
Re: K101809
Trade/Device Name: Fujirebio Diagnostics Tumor Marker Controls Regulation Number: 21 CFR8862.1660 Regulation Name: Quality Control Material, Assayed and Unassayed Regulatory Class: Class I (Reserved) Product Code: JJY Dated: September 3, 2010 Received: September 9, 2010
Dear Ms. Hall:
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 class II (Special Controls), 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
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Page 2 - Ms. Christina Hall
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 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,
Maria M. Chan, Ph.D.
tow Director
Division of Immunology and Hematology 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): K101809
Device Name: Fujirebio Diagnostics Tumor Marker Controls
QCT - 5 2010
Indications for Use:
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Keene Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101809
Page 1 of _
§ 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.