(28 days)
Not Found
No
The description focuses on standard immunoassay calibration and calculation based on a pre-defined curve, with no mention of AI or ML techniques.
No.
This device is a calibrator used for in vitro diagnostic testing, not for direct therapeutic treatment of a patient.
No
The device description indicates that the "Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System." Calibrators are used to establish a calibration curve which allows the system to accurately measure the concentration of FSH in a specimen. Calibrators themselves do not perform the diagnostic measurement; rather, they are a component used to ensure the accuracy of a diagnostic instrument.
No
The device description explicitly states that the device includes physical calibrators (liquids containing FSH) and is used in conjunction with the LUMIPULSE G System, which is a hardware analyzer. The performance studies also detail the testing of these physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first line explicitly states: "Lumipulse G FSH-N Calibrators are for in vitro diagnostic use..." This is a clear and direct indication of its intended purpose.
- Device Description: The description details how the calibrators are used in conjunction with the LUMIPULSE G System to determine the concentration of follicle-stimulating hormone (FSH) in a specimen. This process of analyzing a biological sample outside of the body to obtain diagnostic information is the core definition of an in vitro diagnostic.
- Performance Characteristics: The section on performance characteristics describes studies related to traceability, stability, and value assignment of the calibrators, all of which are relevant to ensuring the accuracy and reliability of an IVD.
- Predicate Device: The mention of a predicate device (K012399 Roche Diagnostics Corporation Elecsys FSH-II CalSet) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
N/A
Intended Use / Indications for Use
Lumipulse® GFSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse GFSH-N on the LUMIPULSE G System.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Master calibration data are recorded in a two-dimensional bar code on the Lumipulse G FSH-N Immunoreaction Cartridge case. The calibration curve is created based on recorded master calibration data and the calibration data. The follicle-stimulating hormone (FSH) concentration of a specimen is automatically calculated from the calibration curve. The result of the calculation is reported in mIU/mL.
Lumipulse® G FSH-N Calibrators:
Lumipulse® G FSH-N Calibrators REF 230930 Each calibrator kit contains one bottle each of calibrators 1 - 2 and consists of the following:
CAL 1 0 mlU/mL FSH calibrator (1 x 1.5 mL) CAL 2 250 mlU/mL FSH calibrator (1 x 1.5 mL) *Contains follicle-stimulating hormone (FSH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
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)
- Analytical performance:
a. Precision/Reproducibility: Not applicable.
b. Linearity/assay reportable range: Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability: The calibrators for use with Lumipulse G FSH-N are prepared gravimetrically and are traceable to the 1st International Standard, 1997 (code 92/510) provided by the National Institute for Biological Standards and Control (NIBSC).
Value Assignment: FSH, Antigen Grade, is obtained from CLINIQA. The 1st stock solution (working stock solution) is prepared by dissolving FSH antigen in 2-amino-2-hydroxymethyl-1,3propandiol-based buffer and then assigned a provisional value based on the measurement in the Lumipulse G FSH-N assay by device of LUMIPULSE G with calibration of secondary calibrators. The calibrator levels are made by calculating the amount of working stock solution and 2-amino-2-hydroxymethyl-1,3-propandiol-based buffer required to achieve the desired teritary 250 mlU/mL calibrator value and adding them together gravimetrically. The 0 mIU/mL Calibrator 1) is just the 2-amino-2-hydroxymethyl-1,3-propandiol-based buffer. The tertiary 250 mlU/mL calibrator is rate-matched to the respective secondary calibrator based on the measurement in the Lumipulse G FSH-N assay and adjusted if necessary. The measurement of tertiary calibrators (each 10 replicates) and secondary calibrators (each 10 replicates) are performed by device of LUMIPULSE G at 3 times. The mean ratio is the mean counts of the secondary calibrator (10 replicates) to the respective tertiary calibrator (10 replicates). The acceptable rate mean ratio is 0.97 - 1.03. This solution is stored at 2 to 10 ℃.
- Stability
Long-term stability conducted at Fujirebio, Inc. (Tokyo, Japan)
Stability of the calibrators is determined by long-term stability study (Tokyo, Japan) using the LUMIPULSE Forte (f) instrument (only sold in Japan). Intended storage and transport stability study is still on-going (Malvern, PA). Based on real-time stability study the sponsor determined that the calibrators have a shelf-life stability of 12 months when stored at 2-10°C. Real-time stability studies for shelf-life and open-vial claims have been conducted and acceptance criteria were met.
Long-term stability data were obtained on the LUMIPULSE f System by measuring the Lumipulse G FSH Calibrators (3 Lots) and samples in replicates of 2 using Lumipulse G FSH Immunoreaction Cartridges (3 Lots) that were stored at 10°C after 0. 3, 7, and 13 months. Sensitivity, accuracy and reproducibility were calculated.
Sensitivity: FSH solutions of 0 and 2 mlU/mL were measured in replicates of 3 at each test point and the luminescence ratio (2 mlU/mL / 0 mlU/mL FSH) were calculated. The results met the criterion of the ratio of ≥20.
Accuracy: 3 serum samples ranged (10.5 - 185.0 mlU/mL) were tested in replicates of 3, measurements at each time point and the variation of ratios against the assigned values were calculated. The results met the criterion within ± 20% for each replicate.
Reproducibility: 3 serum samples ranged (10.5 – 185.0 mlU/mL) were tested in replicates of 6 measurements and CVs of measured values at each time point were calculated. The results met the criterion of 10% CV or less for each sample.
The results of sensitivity, accuracy and reproducibility confirmed that all long-term stability performance up to 13 months met the criteria. Therefore, the shelf life of the Lumipulse G FSH-N Calibrators stored at 2-10°C for 12 months was confirmed.
Real Time (Intended Storage) Stability Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
In the on-going real-time stability study, the Lumipulse G FSH-N calibrators are stored at 2-10ºC. The FSH-N calibrators are tested in duplicate at Month 0 (study initiation), 6, 12 and 13 over the shelf life of the device up to the planned shelf life plus one month (13 months).
Real-time intended storage stability is calculated based on the percent difference for the panels at each time point when compared to the value received at Time Point 0 (study initiation). The mean concentration of each panel from each time point must be within ±10% mean concentration at Study Initiation. For all 3 lots, time Point 2 (month 6) was the second time point for testing and the acceptance criteria was met.
Open-Vial (in-use) Stability Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
In the on-going real-time stability study, the Lumipulse G FSH-N calibrators are stored at 2-10ºC. The FSH-N calibrators are tested in duplicate at Month 0 (study initiation), 6, 12, and 13 over the shelf life of the device up to the planned shelf life plus one month (13 months).
Open-vial (in-use) stability is calculated based on the percent difference for the panels at each time point when compared to the value received at Time Point 0 (study initiation).
The mean concentration of each panel from each time point must be within ±10% mean concentration at Study Initiation. For all 3 lots, time Point 2 (month 6) was the second time point for testing and the acceptance criteria was met.
Transport Simulation
a. Transport Simulation study conducted at Fujirebio, Inc. (Tokyo, Japan)
The transport simulation stability of the Lumipulse G FSH-N Calibrators that are packed for overseas transportation was examined in terms of temperature.
For the temperature test, the calibrators were stored in the following condition: 37 °C 48±2 hours → -20 ℃ 48±2 hours → 30 ℃ 96±4 hours → 4 ℃ 24±2 hours.
To determine the impact of temperature on the Lumipulse G FSH-N Calibrators, a performance analysis was conducted.
The performance analysis calculated sensitivity and accuracy. For sensitivity, the luminescence ratio (FSH-N calibrator 2 / FSH-N calibrator 1) was calculated. The criterion was a ratio greater than or equal to 21. For accuracy, the variation for each calibrator was calculated using the ratio of the measured values (n=1) against the assigned values. The criterion was ratios within 100±20%.
The luminescence ratio was 90 under control conditions and 87 under stress conditions and met the criteria of ≥ 10. The accuracy ranged from 99-108% under control conditions and 96-104% under stress conditions and met the criteria of 100±20%.
The results of the performance analysis confirmed that all stability criteria for transport simulation tests were met. Therefore, the temperature stress used in the test had no impact on the Lumipulse G FSH-N.
b. Transport Simulation Stability Study Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
Transport simulation of the Lumipulse G FSH-N calibrators was examined in terms of temperature. For the temperature test, the calibrators were stored in the following condition: 37 °C 24±2 hours → 25 °C 24±2 hours → -20 °C 24±2 hours → 6 °C 24±2 hours. To determine the impact of temperature on the Lumipulse G FSH-N Calibrators, a performance analysis was conducted.
After each stress condition, all Lumipulse G FSH-N ICs and Lumipulse G FSH-N Calibrators were moved to the next cycle temperature. After all cycles were complete, a visual inspection was performed and the Lumipulse G FSH-N calibrators were stored at the intended storage condition of 2-10°C. Stressed Lumipulse G FSH-N IC's and Calibrators were tested within 3 calendar days after the completion of all cvcles. Calibrators were tested in duplicate, controls in replicates of 1 and panels in replicates of 3.
At study initiation, the assay met the acceptance criteria of %CV ≤10% for all transport conditions tested. The stability study is still ongoing.
Shelf life: The shelf life for Lumipulse G FSH-N Calibrators is 12 months at 2-10°C.
d. Detection limit: Not applicable.
e. Analytical specificity: Not applicable.
f. Assay cut-off: Not applicable.
1 Comparison studies: Not applicable.
a. Method Comparison Not applicable.
b. Matrix Comparison Not applicable.
2 Clinical studies: Not applicable.
a. Clinical sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable
3 Clinical cut-off: Not applicable.
4 Expected values/Reference range: Not applicable.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2017
FUJIREBIO DIAGNOSTICS, INC. DIANA DICKERSON DIRECTOR, CLINICAL AND REGULATORY SCIENCE 201 GREAT VALLEY PARKWAY MALVERN PA 19355
Re: K163534
Trade/Device Name: Lumipulse® G FSH-N Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: December 15, 2016 Received: December 16, 2016
Dear Diana Dickerson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Lumipulse® GFSH-N Calibrators
Indications for Use (Describe)
Lumipulse GFSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse GFSH-N on the
LUMIPULSE G System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 4
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Image /page/3/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and white abstract symbol on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc."
Section 5 510(k) SUMMARY
Lumipulse® G FSH-N Calibrators
- January 9, 2017 Date:
- 510(k) Number: K163534
- Fujirebio Diagnostics, Inc. Submitter: 201 Great Valley Parkway Malvern, PA 19355
- Contact Person: Stacey Dolan Manager, Requlatory Affairs Phone: (610) 240-3843 Fax: (610) 240-3803 Email: dolans@fdi.com
- Lumipulse® G FSH-N Calibrators Device Name: Classification: Class II JIT 75, Clinical Chemistry 21 CFR § 862.1150
- K012399 Predicate Device: Roche Diagnostics Corporation Elecsys FSH-II CalSet
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Device Description:
Master calibration data are recorded in a two-dimensional bar code on the Lumipulse G FSH-N Immunoreaction Cartridge case. The calibration curve is created based on recorded master calibration data and the calibration data. The follicle-stimulating hormone (FSH) concentration of a specimen is automatically calculated from the calibration curve. The result of the calculation is reported in mIU/mL.
Lumipulse® G FSH-N Calibrators:
Lumipulse® G FSH-N Calibrators REF 230930 Each calibrator kit contains one bottle each of calibrators 1 - 2 and consists of the following:
CAL 1 0 mlU/mL FSH calibrator (1 x 1.5 mL) CAL 2 250 mlU/mL FSH calibrator (1 x 1.5 mL) *Contains follicle-stimulating hormone (FSH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
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Image /page/4/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left, resembling a water droplet or a stylized "Y", with blue and green vertical lines. To the right of the graphic is the company name, "FUJIREBIO", in large, bold, blue letters. Below the company name is the text "Diagnostics, Inc." in a smaller, lighter font.
Device Intended Use:
Lumipulse G FSH-N Calibrators
Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System.
Device Indications for Use:
Same as Intended Use
Substantial Equivalence:
Comparison between the Lumipulse G FSH-N Calibrators and Roche Diagnostics Corporation, Elecsys FSH-II CalSet
| Calibrator Set | |||
|---|---|---|---|
| Similarities and Differences | |||
| Parameter | Lumipulse G | ||
| FSH-N Calibrators | |||
| (Proposed Device) | Elecsys FSH-II CalSet | ||
| (Predicate Device) | |||
| K012399 | |||
| Format | Liquid; Ready for use | Lyophilized | |
| Matrix | Tris buffer with bovine stabilizer | Human serum with added | |
| human FSH | |||
| Levels | Two levels | Two levels | |
| Intended Use | Lumipulse G FSH-N Calibrators | ||
| are for in vitro diagnostic use in | |||
| the calibration of Lumipulse G | |||
| FSH-N on the LUMIPULSE G | |||
| System. | Elecsys FSH II CalSet used | ||
| for calibrating the quantitative | |||
| Elecsys FSH assay on the | |||
| Elecsys and cobas e | |||
| immunoassay analyzers. | |||
| Stability | Stable at 2-10ºC until expired | Stable at 2-8ºC until expired |
Performance Characteristics
Data were generated using the LUMIPULSE G1200 System.
-
- Analytical performance:
- a. Precision/Reproducibility: Not applicable.
- b. Linearity/assay reportable range: Not applicable.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceabilitv
The calibrators for use with Lumipulse G FSH-N are prepared gravimetrically and are traceable to the 1* International Standard, 1997 (code 92/510) provided by the National Institute for Biological Standards and Control (NIBSC).
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Image /page/5/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and green abstract shape on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc."
Value Assignment
FSH, Antigen Grade, is obtained from CLINIQA. The 1st stock solution (working stock solution) is prepared by dissolving FSH antigen in 2-amino-2-hydroxymethyl-1,3propandiol-based buffer and then assigned a provisional value based on the measurement in the Lumipulse G FSH-N assay by device of LUMIPULSE G with calibration of secondary calibrators. The calibrator levels are made by calculating the amount of working stock solution and 2-amino-2-hydroxymethyl-1,3-propandiol-based buffer required to achieve the desired teritary 250 mlU/mL calibrator value and adding them together gravimetrically. The 0 mIU/mL Calibrator 1) is just the 2-amino-2-hydroxymethyl-1,3-propandiol-based buffer. The tertiary 250 mlU/mL calibrator is rate-matched to the respective secondary calibrator based on the measurement in the Lumipulse G FSH-N assay and adjusted if necessary. The measurement of tertiary calibrators (each 10 replicates) and secondary calibrators (each 10 replicates) are performed by device of LUMIPULSE G at 3 times. The mean ratio is the mean counts of the secondary calibrator (10 replicates) to the respective tertiary calibrator (10 replicates). The acceptable rate mean ratio is 0.97 - 1.03. This solution is stored at 2 to 10 ℃.
-
- Stability
Long-term stability conducted at Fujirebio, Inc. (Tokyo, Japan)
Stability of the calibrators is determined by long-term stability study (Tokyo, Japan) using the LUMIPULSE Forte (f) instrument (only sold in Japan). Intended storage and transport stability study is still on-going (Malvern, PA). Based on real-time stability study the sponsor determined that the calibrators have a shelf-life stability of 12 months when stored at 2-10°C. Real-time stability studies for shelf-life and open-vial claims have been conducted and acceptance criteria were met.
*Note: (The LUMIPULSE f System uses the same Lumipulse G FSH-N Calibrators as the LUMIPULSE G1200 System)
Long-term stability
The long-term stability data were obtained on the LUMIPULSE f System by measuring the Lumipulse G FSH Calibrators (3 Lots) and samples in replicates of 2 using Lumipulse G FSH Immunoreaction Cartridges (3 Lots) that were stored at 10°C after 0. 3, 7, and 13 months. Sensitivity, accuracy and reproducibility were calculated.
Sensitivity
FSH solutions of 0 and 2 mlU/mL were measured in replicates of 3 at each test point and the luminescence ratio (2 mlU/mL / 0 mlU/mL FSH) were calculated. The results met the criterion of the ratio of ≥20.
Accuracy
3 serum samples ranged (10.5 - 185.0 mlU/mL) were tested in replicates of 3, measurements at each time point and the variation of ratios against the assigned values were calculated. The results met the criterion within ± 20% for each replicate.
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Image /page/6/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and green abstract symbol on the left, followed by the company name in blue, bold letters. Below the company name, the words "Diagnostics, Inc." are written in a smaller, black font.
Reproducibility
3 serum samples ranged (10.5 – 185.0 mlU/mL) were tested in replicates of 6 measurements and CVs of measured values at each time point were calculated. The results met the criterion of 10% CV or less for each sample.
The results of sensitivity, accuracy and reproducibility confirmed that all long-term stability performance up to 13 months met the criteria. Therefore, the shelf life of the Lumipulse G FSH-N Calibrators stored at 2-10°C for 12 months was confirmed.
Real Time (Intended Storage) Stability Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
Real-time (Intended Storage) stability is being evaluated as follows: In the on-going real-time stability study, the Lumipulse G FSH-N calibrators are stored at 2-10ºC. The FSH-N calibrators are tested in duplicate at Month 0 (study initiation), 6, 12 and 13 over the shelf life of the device up to the planned shelf life plus one month (13 months).
Real-time intended storage stability is calculated based on the percent difference for the panels at each time point when compared to the value received at Time Point 0 (study initiation). The mean concentration of each panel from each time point must be within ±10% mean concentration at Study Initiation. For all 3 lots, time Point 2 (month 6) was the second time point for testing and the acceptance criteria was met.
The testing will continue with this stability protocol until data to support a claim of 12 months is achieved.
Open-Vial (in-use) Stability Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
Open-Vial (in-use) stability is being evaluated as follows:
In the on-going real-time stability study, the Lumipulse G FSH-N calibrators are stored at 2-10ºC. The FSH-N calibrators are tested in duplicate at Month 0 (study initiation), 6, 12, and 13 over the shelf life of the device up to the planned shelf life plus one month (13 months).
Open-vial (in-use) stability is calculated based on the percent difference for the panels at each time point when compared to the value received at Time Point 0 (study initiation).
The mean concentration of each panel from each time point must be within ±10% mean concentration at Study Initiation. For all 3 lots, time Point 2 (month 6) was the second time point for testing and the acceptance criteria was met.
The testing will continue with this stability protocol until data to support a claim of 12 months is achieved.
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Image /page/7/Picture/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc." The logo consists of a stylized graphic on the left, featuring blue and green shapes that resemble a water droplet or a stylized flower. To the right of the graphic, the word "FUJIREBIO" is written in large, bold, blue letters. Below "FUJIREBIO", the words "Diagnostics, Inc." are written in a smaller, black font.
Transport Simulation
a. Transport Simulation study conducted at Fujirebio, Inc. (Tokyo, Japan)
The transport simulation stability of the Lumipulse G FSH-N Calibrators that are packed for overseas transportation was examined in terms of temperature.
For the temperature test, the calibrators were stored in the following condition: 37 °C 48±2 hours → -20 ℃ 48±2 hours → 30 ℃ 96±4 hours → 4 ℃ 24±2 hours.
To determine the impact of temperature on the Lumipulse G FSH-N Calibrators, a performance analysis was conducted.
The performance analysis calculated sensitivity and accuracy. For sensitivity, the luminescence ratio (FSH-N calibrator 2 / FSH-N calibrator 1) was calculated. The criterion was a ratio greater than or equal to 21. For accuracy, the variation for each calibrator was calculated using the ratio of the measured values (n=1) against the assigned values. The criterion was ratios within 100±20%.
The luminescence ratio was 90 under control conditions and 87 under stress conditions and met the criteria of ≥ 10. The accuracy ranged from 99-108% under control conditions and 96-104% under stress conditions and met the criteria of 100±20%.
The results of the performance analysis confirmed that all stability criteria for transport simulation tests were met. Therefore, the temperature stress used in the test had no impact on the Lumipulse G FSH-N.
b. Transport Simulation Stability Study Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
Transport simulation of the Lumipulse G FSH-N calibrators was examined in terms of temperature. For the temperature test, the calibrators were stored in the following condition: 37 °C 24±2 hours → 25 °C 24±2 hours → -20 °C 24±2 hours → 6 °C 24±2 hours. To determine the impact of temperature on the Lumipulse G FSH-N Calibrators, a performance analysis was conducted.
After each stress condition, all Lumipulse G FSH-N ICs and Lumipulse G FSH-N Calibrators were moved to the next cycle temperature. After all cycles were complete, a visual inspection was performed and the Lumipulse G FSH-N calibrators were stored at the intended storage condition of 2-10°C. Stressed Lumipulse G FSH-N IC's and Calibrators were tested within 3 calendar days after the completion of all cvcles. Calibrators were tested in duplicate, controls in replicates of 1 and panels in replicates of 3.
At study initiation, the assay met the acceptance criteria of %CV ≤10% for all transport conditions tested. The stability study is still ongoing.
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Image /page/8/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and green abstract symbol on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc.", which is placed below it. The overall design is clean and professional.
Shelf life
The shelf life for Lumipulse G FSH-N Calibrators is 12 months at 2-10°C.
Transport conditions
Lumipulse G FSH-N Calibrators are shipped at 2-10°C. Materials will be shipped to the end user using an insulated container and a predetermined configuration of gel (cold and/or frozen) packs to maintain the product for up to 72 hours when stored at ambient temperature.
- d. Detection limit: Not applicable.
- e. Analytical specificity: Not applicable.
- f. Assay cut-off: Not applicable.
- 1 Comparison studies: Not applicable.
- a. Method Comparison Not applicable.
- b. Matrix Comparison Not applicable.
- 2 Clinical studies: Not applicable.
a. Clinical sensitivity: Not applicable
b. Clinical specificity: Not applicable
Other clinical supportive data (when a. and b. are not applicable): C. Not applicable
- 3 Clinical cut-off: Not applicable.
- Expected values/Reference range: 4 Not applicable.
Proposed Labeling
The labeling satisfies the requirements of 21 CFR Part 809.10.
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Standard/Guidance Document Referenced:
- . ISO 17511:2003 Measurement of Quantities in Biological Samples - Metrological Traceability of Values Assigned to Calibrator and Control Materials
- CLSI EP25-A - Evaluation of Stability of In Vitro Diagnostic Reagents: Approved Guideline
- . Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions (December 3, 2015)
- Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s (August 4, 2015)
- Guidance Document - Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.