(28 days)
Not Found
No
The device is a set of calibrators for an immunoassay system, not a system that processes data or makes decisions using AI/ML. The description focuses on the chemical composition and stability of the calibrators.
No.
The Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of an analytical system, not for direct therapeutic treatment of a patient.
No
The device is a calibrator, used in the calibration of a diagnostic system, not a diagnostic device itself.
No
The device is a calibrator kit containing liquid solutions with specific chemical compositions, clearly indicating it is a physical product and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Progesterone-N on the LUMIPULSE G System."
This statement directly indicates that the device is intended for use in diagnostic procedures performed outside of the body (in vitro).
N/A
Intended Use / Indications for Use
Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Progesterone-N on the LUMIPULSE G System.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Lumipulse G Progesterone-N Calibrator kit contains 3 bottles (1.5 mL each) of Lumipulse G Progesterone-N Calibrators 1, 2, and 3. Calibrators 1, 2, and 3 contain progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.
Lumipulse G Progesterone-N Calibrators CAL 230893, Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.
CAL 1 0 ng/mL Progesterone calibrator (1 × 1.5 mL)
CAL 2 0.5 ng/mL Progesterone calibrator (1 x 1.5 mL)
40 ng/mL Progesterone calibrator (1 x 1.5 mL)
CAL 3 *Contains progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.
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
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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:
- Precision/Reproducibility: Not applicable.
- Linearity/assay reportable range: Not applicable.
- Traceability, Stability, Expected values (controls, calibrators, or methods):
- Traceability: The calibrators for use with Lumipulse G Progesterone-N are prepared gravimetrically and are traceable to ERM-DA347 and BCR-348R by IRMM (Institute for Reference Materials and Measurements).
- Value Assignment: Progesterone, ≥ 99 % is obtained from SIGMA-ALDRICH. The Progesterone solution was prepared by dissolving Progesterone. ≥ 99 % in ethanol. The Progesterone solution is spiked into 2-Morpholinoethanesulfonic acid-based buffer and then assigned a provisional value based on the measurement in the Lumipulse G Progesterone-N assay. The mean value (6 replicates) by LUMIPULSE G was assigned a provisional value. This solution is used as 1st stock solution (working stock solution). The calibrator levels are made by calculating the amount of working stock solution and 2-Morpholinoethanesulfonic acid-based buffer required to achieve the desired tertiary 40 ng/mL calibrator value and adding them together gravimetrically. Dilutions are made gravimetrically using one part of the tertiary 40 ng/mL calibrator and 2-Morpholinoethanesulfonic acid-based buffer to obtain secondary 0.5 ng/mL calibrator. The 0 ng/mL Calibrator (Calibrator 1) is just the 2-Morpholinoethanesulfonic acid-based buffer. These tertiary calibrators are rate-matched to the respective secondary calibrator based on the measurement in the Lumipulse G Progesterone-N assay and adjusted if necessary. The measurement of tertiary calibrators (10 replicates) and secondary calibrators (10 replicates) are performed 3 runs each using LUMIPULSE G. The mean ratio is the mean counts of each primary calibrator (10 replicates) to the respective original calibrators (10 replicates). The acceptable rate mean ratio is 0.95 - 1.05. This is the assigned value. This solution is stored at 2 to 10 °C.
- Stability:
- Long-term stability conducted at Fujirebio, Inc. (Tokyo, Japan)
- Sensitivity: Lumipulse G Progesterone-N Calibrator 1 and Lumipulse G Progesterone-N Calibrator 2 in duplicate at each test point and the luminescence ratio (Progesterone-N calibrator 1/ Progesterone-N calibrator 2) were calculated. The results met the criterion of the ratio of 1.2 or greater.
- Accuracy: 3 samples of serum (3.15 - 24.42 ng/mL) were tested in replicates of 6, measurements at each time point and the variation of the measured values to the assigned values were calculated. The results met the criterion within 100 ± 20% for each replicate.
- Reproducibility: 3 samples (3.15 - 24.42 ng/mL) were tested in replicates of 6 and CVs of measured values at each time point were calculated. The results met the criterion of 15% or less for each sample.
- Key results: The results of sensitivity, accuracy and reproducibility confirmed that all long-term stability performance up to 9 months met the criteria. Therefore, the shelf life of the Lumipulse G Progesterone-N Calibrators stored at 2-10°C for 9 months was confirmed.
- Real Time (Intended Storage) Stability Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
- Key results: Time Point 2 (Month 4) was the second time point for testing. The Lumipulse G Progesterone-N calibrators were determined to be stable at the intended storage conditions for up to 4 months for all 3 lots; therefore acceptance criteria were met. The shelf life for Lumipulse G Progesterone-N Calibrators is 9 months at 2-10°C.
- Open-vial (In-Use) Stability Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
- Key results: Time Point 2 (Month 4) was the second time point for testing. Acceptance criteria were met for this time point.
- Transport Simulation:
- a. Transport Simulation conducted at Fujirebio, Inc. (Tokyo, Japan)
- For sensitivity, the luminescence ratio (Progesterone-N calibrator 1 / Progesterone-N calibrator 2) was calculated. The criterion was a ratio greater than or equal to 1.2. The accuracy of each panel was the acceptance criteria of variation within 100±20%.
- Key results: The luminescence ratio was 1.6 and met the criteria of ≥ 1.2. The accuracy ranged from 86-120% 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 Progesterone-N.
- b. Transport Simulation Stability Study conducted at Fuiirebio Diagnostics. Inc. (Malvern, PA)
- Key results: At study initiation, the assay met the acceptance criteria of %CV≤ 10% for all transport conditions tested and the appearance of the IC met the visual inspection criteria. At 4 months, the mean concentration of each panel was within ± 10% of the mean concentration at Study Initiation for all transport conditions tested. The assay met the acceptance criteria of %CV ≤ 10% for all transport conditions tested and the appearance of the IC met the visual inspection criteria.
- a. Transport Simulation conducted at Fujirebio, Inc. (Tokyo, Japan)
- Long-term stability conducted at Fujirebio, Inc. (Tokyo, Japan)
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Comparison studies:
- a. Method Comparison: Not applicable.
- b. Method Comparison: Not applicable.
- c. Matrix Comparison: Not applicable.
-
Clinical studies: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity: The luminescence ratio was 1.6 and met the criteria of ≥ 1.2.
- Accuracy: The accuracy ranged from 86-120% and met the criteria of 100±20%.
- Reproducibility: CVs of measured values met the criterion of 15% or less.
- At study initiation, the assay met the acceptance criteria of %CV≤ 10% for all transport conditions tested. At 4 months, the mean concentration of each panel was within ± 10% of the mean concentration at Study Initiation for all transport conditions tested. The assay met the acceptance criteria of %CV ≤ 10% for all transport conditions tested.
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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2017
FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN MANAGER, REGULATORY AFFAIRS 201 GREAT VALLEY PARKWAY MALVERN PA 19355
Re: K163546
Trade/Device Name: Lumipulse® G Progesterone-N Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: December 15, 2016 Received: December 16, 2016
Dear Stacey Dolan:
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
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Indications for Use
510(k) Number (if known) K163546
Device Name Lumipulse® G Progesterone-N
Indications for Use (Describe) Lumipulse G Progesterone-N Calibrators
Lumipulse & Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse & Progesterone-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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Image /page/3/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 combination of blue and green shapes, with a white teardrop shape in the center. The company name is written in blue, with "Fujirebio" on the top line and "Diagnostics, Inc." on the bottom line.
Section 5 510(k) SUMMARY
Lumipulse® G Progesterone-N
Date: January 9, 2017
510(k) Number: K163546
- 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 Progesterone-N Calibrators Device Name: Classification: Class II JIT 75, Clinical Chemistry 21 CFR § 862.1150
- Predicate Device: K152526 ROCHE DIAGNOSTICS Elecsys Progesterone III 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:
Lumipulse G Progesterone-N Calibrator kit contains 3 bottles (1.5 mL each) of Lumipulse G Progesterone-N Calibrators 1, 2, and 3. Calibrators 1, 2, and 3 contain progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.
Lumipulse G Progesterone-N Calibrators CAL 230893, Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.
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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 and the company name on the right. The graphic is a blue and green design with a white teardrop shape in the center. The company name is written in blue, with "FUJIREBIO" on the top line and "Diagnostics, Inc." on the bottom line.
CAL 1 0 ng/mL Progesterone calibrator (1 × 1.5 mL) CAL 2 0.5 ng/mL Progesterone calibrator (1 x 1.5 mL) 40 ng/mL Progesterone calibrator (1 x 1.5 mL) CAL 3 *Contains progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.
Device Intended Use:
Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Progesterone-N on the LUMIPULSE G System.
Device Indications for Use:
Same as Intended Use
Substantial Equivalence:
Comparison between the Lumipulse G Progesterone-N Calibrators and Roche Diagnostics Elecsys Progesterone II CalSet
| Calibrator Set | ||
|---|---|---|
| Similarities and Differences | ||
| Parameter | Lumipulse G | |
| Progesterone-N | ||
| (Proposed Device) | Elecsys Progesterone II CalSet | |
| (Predicate Device) | ||
| K152526 | ||
| Intended Use | Lumipulse G Progesterone-N Calibrators | |
| are for in vitro diagnostic use in the | ||
| calibration of Lumipulse G | ||
| Progesterone-N on the LUMIPULSE G | ||
| System. | Progesterone III CalSet is used for | |
| calibrating the quantitative Elecsys | ||
| Progesterone III assay on the | ||
| Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Instrument System | LUMIPULSE G System | Elecsys and cobas e |
| immunoassay analyzers | ||
| Analyte | Progesterone | Same |
| Number of Calibrators | 3 calibrators | 2 calibrators |
| Standardization/Traceability | Calibration of the LUMIPULSE G | |
| Progesterone-N are prepared | ||
| gravimetrically and are traceable to | ||
| ERM-DA347 and BCR-348R by IRMM | ||
| (Institute for Reference Materials and | ||
| Meausrements) | The assay is traceable via ID- | |
| GC/MS (isotope dilution gas | ||
| chromatography/mass | ||
| spectrometry) to highly purified | ||
| progesterone by weight analogous | ||
| to BCR-348R and ERM-DA347. | ||
| Level | 3 levels of 0 ng/mL,0.5 ng/mL-40 ng/mL | 2 levels0.080 ng/mL-53 ng/mLConcentrations are lot specific |
| Form | Liquid - ready to use | Same |
| Matrix | Sodium chloride in MES buffer with | |
| protein (bovine) and chemical stabilizers. | ||
| Preservative: sodium azide. | Human serum |
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Image /page/5/Picture/1 description: The image contains the logo for Fujirebio Diagnostics, Inc. The logo features a stylized graphic on the left, consisting of blue and green shapes. 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, lighter font.
Performance Characteristics
Data were generated using the LUMIPULSE G1200 System.
-
- Analytical performance:
- a. Precision/Reproducibility: Not applicable.
- b. Linearity/assay reportable range: Not applicable.
- Traceability, Stability, Expected values (controls, calibrators, or methods): ﯼ ﻧ
Traceability
The calibrators for use with Lumipulse G Progesterone-N are prepared gravimetrically and are traceable to ERM-DA347 and BCR-348R by IRMM (Institute for Reference Materials and Measurements).
Value Assignment
Progesterone, ≥ 99 % is obtained from SIGMA-ALDRICH. The Progesterone solution was prepared by dissolving Progesterone. ≥ 99 % in ethanol. The Progesterone solution is spiked into 2-Morpholinoethanesulfonic acid-based buffer and then assigned a provisional value based on the measurement in the Lumipulse G Progesterone-N assay. The mean value (6 replicates) by LUMIPULSE G was assigned a provisional value. This solution is used as 1st stock solution (working stock solution). The calibrator levels are made by calculating the amount of working stock solution and 2-Morpholinoethanesulfonic acid-based buffer required to achieve the desired tertiary 40 ng/mL calibrator value and adding them together gravimetrically. Dilutions are made gravimetrically using one part of the tertiary 40 ng/mL calibrator and 2-Morpholinoethanesulfonic acid-based buffer to obtain secondary 0.5 ng/mL calibrator. The 0 ng/mL Calibrator (Calibrator 1) is just the 2-Morpholinoethanesulfonic acid-based buffer. These tertiary calibrators are rate-matched to the respective secondary calibrator based on the measurement in the Lumipulse G Progesterone-N assay and adjusted if necessary. The measurement of tertiary calibrators (10 replicates) and secondary calibrators (10 replicates) are performed 3 runs each using LUMIPULSE G. The mean ratio is the mean counts of each primary calibrator (10 replicates) to the respective original calibrators (10 replicates). The acceptable rate mean ratio is 0.95 - 1.05. This is the assigned value. This solution is stored at 2 to 10 °C.
-
- Stability
Long-term stability conducted at Fujirebio, Inc. (Tokyo, Japan)
The long-term stability data were obtained on the LUMIPULSE G1200 System by measuring the Progesterone-N calibrators and samples for 3 lots of reagents that were
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Image /page/6/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 blue and green abstract shape. The company name is written in blue, with "FUJIREBIO" on the top line and "Diagnostics, Inc." on the bottom line.
stored at 10°C for 0, 1, 2, 3, 6, 9 months. Sensitivity, accuracy and reproducibility were calculated.
Sensitivity
Lumipulse G Progesterone-N Calibrator 1 and Lumipulse G Progesterone-N Calibrator 2 in duplicate at each test point and the luminescence ratio (Progesterone-N calibrator 1/ Progesterone-N calibrator 2) were calculated. The results met the criterion of the ratio of 1.2 or greater.
Accuracy
3 samples of serum (3.15 - 24.42 ng/mL) were tested in replicates of 6, measurements at each time point and the variation of the measured values to the assigned values were calculated. The results met the criterion within 100 ± 20% for each replicate.
Reproducibility
3 samples (3.15 - 24.42 ng/mL) were tested in replicates of 6 and CVs of measured values at each time point were calculated. The results met the criterion of 15% or less for each sample.
The results of sensitivity, accuracy and reproducibility confirmed that all long-term stability performance up to 9 months met the criteria. Therefore, the shelf life of the Lumipulse G Progesterone-N Calibrators stored at 2-10°C for 9 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 Progesterone-N calibrators are stored at 2-10 C. The Progesterone-N calibrators are tested in duplicate at specified intervals of 4 months and 9 months over the shelf life of the device up to the planned shelf life plus one month (10 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).
Time Point 2 (Month 4) was the second time point for testing. The Lumipulse G Progesterone-N calibrators were determined to be stable at the intended storage conditions for up to 4 months for all 3 lots; therefore acceptance criteria were met.
The testing will continue with this stability protocol until data to support a claim of 9 months is achieved.
The shelf life for Lumipulse G Progesterone-N Calibrators is 9 months at 2-10°C.
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Image /page/7/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 combination of blue and green shapes, possibly representing water droplets or leaves. The company name is written in a bold, blue font, with "FUJIREBIO" on the top line and "Diagnostics, Inc." on the bottom line.
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 open-vial stability study(included in the real-time stability study), the Lumipulse G Progesterone-N calibrators are stored at 2-10 C and all 3 calibrators were opened and closed at the start of the study. (Time Point). The Progesterone-N calibrators are tested in duplicate at specified intervals of 4 months and 9 months over the shelf life of the device up to the planned shelf life plus one month (10 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).
Time Point 2 (Month 4) was the second time point for testing. Acceptance criteria were met for this time point. The testing will continue with this stability protocol until data to support a claim of 9 months is achieved.
Transport Simulation
- a. Transport Simulation conducted at Fujirebio, Inc. (Tokyo, Japan)
The transport simulation stability of the Lumipulse G Progesterone-N Calibrators that are packed for overseas transportation was examined in terms of temperature.
For the temperature test, the calibrators were stressed at the following conditions: 37 °C 48±2 hours (Cumulative Interval 2 days) → -20 ℃ 48±2 hours (Cumulative Interval 4 days) -> 30 °C 96±2 hours (Cumulative Interval 8 davs) -> 4 °C 24±2 hours (Cumulative Interval 9 days).
To determine the impact of temperature on the Lumipulse G Progesterone-N Calibrators, a performance analysis was conducted. The concentration of the panel replicates were determined by using the calibration curve generated for each condition.
The performance analysis calculated sensitivity and accuracy. For sensitivity, the luminescence ratio (Progesterone-N calibrator 1 / Progesterone-N calibrator 2) was calculated. The criterion was a ratio greater than or equal to 1.2. The accuracy of each panel was the acceptance criteria of variation within 100±20%.
The luminescence ratio was 1.6 and met the criteria of ≥ 1.2. The accuracy ranged from 86-120% 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 Progesterone-N.
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Image /page/8/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized blue and green symbol on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc."
- b. Transport Simulation Stability Study conducted at Fuiirebio Diagnostics. Inc. (Malvern, PA)
Transport simulation of the Lumipulse G Progesterone-N calibrators was examined in terms of temperature. For the temperature test, the calibrators were stored in the following condition: 37 C ± 2 C 24±2 hours → 25 C ± 2 C 24±2 hours → -20 C ± 2 C 24±2 hours → 6 C ± 2 C 24±2 hours. To determine the impact of temperature on the Lumipulse G Progesterone-N Calibrators, a performance analysis was conducted.
After each stress condition, all Lumipulse G Progesterone-N ICs and Lumipulse G Progesterone-N Calibrators were moved to the next cycle temperature. After all cycles were complete, a visual inspection was performed and the Lumipulse G Progesterone-N calibrators were stored at the intended storage condition of 2-10℃. Stressed Lumipulse G Progesterone-N IC's and Calibrators were tested within 3 calendar days after the completion of all cycles. Calibrators were tested in duplicate, controls in singlicate and panels in triplicate.
At study initiation, the assay met the acceptance criteria of %CV≤ 10% for all transport conditions tested and the appearance of the IC met the visual inspection criteria. At 4 months, the mean concentration of each panel was within ± 10% of the mean concentration at Study Initiation for all transport conditions tested. The assay met the acceptance criteria of %CV ≤ 10% for all transport conditions tested and the appearance of the IC met the visual inspection criteria. The stability study is ongoing.
Lumipulse G Progesterone-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.
3. Comparison studies:
- a. Method Comparison: Not applicable.
- b. Method Comparison:
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Image /page/9/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and green abstract design 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, non-bold font.
Not applicable.
- c. Matrix Comparison: Not applicable.
- Clinical studies: 4.
- a. Clinical sensitivity: Not applicable.
- b. Clinical specificity: Not applicable.
- c. Other clinical supportive data (when a. and b. are not applicable): Not applicable.
-
- Clinical cut-off: Not applicable.
-
- Expected values/Reference range: Not applicable.
Proposed Labelling
The labelling satisfies the requirements of 21 CFR Part 809.10.
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 (February 22, 1999)
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.