(30 days)
Not Found
No
The document describes a calibrator kit for an in vitro diagnostic test. The description focuses on the chemical composition, packaging, and performance characteristics (stability, traceability) of the calibrators. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as a calibrator for in vitro diagnostic use, meaning it's used to calibrate laboratory equipment for testing, not to treat a condition or disease.
No
The device is a calibrator for in vitro diagnostic use, meaning it is used to calibrate diagnostic instruments, not to directly diagnose patients.
No
The device is a calibrator kit containing liquid reagents and is intended for in vitro diagnostic use with a specific hardware system (LUMIPULSE® G System). It is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "Lumipulse & E2-III Calibrators are for in vitro diagnostic use". This is the most direct indicator.
- Device Description: The description details the composition of the calibrators, which are used in a laboratory setting to calibrate an instrument (LUMIPULSE® G System) for measuring a substance (estradiol) in a biological sample. This aligns with the definition of an in vitro diagnostic device.
- Performance Studies: The performance studies described (Analytical performance, Stability) are typical evaluations conducted for IVD devices to ensure their reliability and accuracy in a diagnostic context.
- Predicate Device: The mention of a predicate device (K142021 Roche Diagnostics Elecsys Estradiol III CalSet) which is also an IVD calibrator, further supports the classification of this device as an IVD.
The information provided clearly indicates that this device is intended to be used outside of the body to examine specimens for diagnostic purposes, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lumipulse® G E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G E2-III on the LUMIPULSE® G System.
Product codes
JIT
Device Description
The Lumipulse G E2-III Calibrator kit contains 3 bottles (1.5mL each) of Lumipulse G E2-III Calibrators 1, 2 and 3. Calibrators 1 – 3 contain estradiol in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Lumipulse G E2-III Calibrators CAL 233849. Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.
CAL 1 E2 calibrator 1 (1 × 1.5 mL)
E₂ calibrator 2 (1 x 1.5 mL) CAL 2
CAL 3 E2 calibrator 3 (1 × 1.5 mL)
*Contains 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
The calibrator values vary for each lot. The actual values are printed on the calibration card included in the kit.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. 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 E2-III are prepared gravimetrically and are traceable to BCR-577 by IRMM (Institute for Reference Materials and Measurements) and verified against ID-GC/MS.
Value Assignment:
The 2000 pg/mL Calibrator (CAL3), the 0 pg/mL Calibrator (CAL1) and the Calibrator2 (approximately 50 pg/mL) are prepared by the following method: Teritary calibrator used ESTRADIOL from Pharmaceutical and Medical Device Regulatory Science Society of Japan. The E solution is prepared by dissolving ESTRADIOL in ethanol. The E 1st stock solution is prepared by spiking the E solution into 2-amino-2-hydroxymethyl-1,3propandiol-based buffer. A 200 stock solution (working stock solution) is prepared by spiking the E2 1st stock solution into 2-amino-2-hydroxymethyl-1,3-propandiol-based buffer. CAL3 is prepared gravimetrically from the working stock solution to achieve the desired value 2000 pg/mL, and is rate-matched to the secondary calibrators based on the measurement in the Lumipulse G E -- III assay and adjusted if necessary. Dilutions are made gravimetrically using one part of CAL3 and 2-amino-2-hydroxymethyl-1.3propandiol-based buffer to obtain CAL2. CAL3 and CAL1 are rate-matched to the secondary calibrators based on the measurement in the Lumipulse G E2-III assay and adjusted if necessary. The tertiary calibrators are measured in 10 replicates, 3 runs on LUMIPULSE G instruments. The acceptable rate mean ratio of CAL3 or CAL1 is 0.95 -1.05. The mean ratio is the mean counts of each tertiary calibrator (10 replicates) to the respective secondary calibrators (10 replicates). For CAL2 value assignment, CAL2 and secondary calibrators are measured in 10 replicates, 3 runs on LUMIPULSE G instruments. The measurement value of CAL2 is calculated from the calibration curve of secondary calibrators in each run using the average of 3 runs for the assigned value. The acceptable value of CAL2 is -20% - +20% range of 50 pg/mL. Calibrator 2 is value assigned and therefore values vary for each lot. The actual values are printed on the calibration card included in the kit. Calibrators 1 and 3 are rate matched and have assigned values of 0 pg/mL for Calibrator 1 and 2000 pg/mL for Calibrator 3. The level of uncertainty around Calibrator 3 is 5%.
Stability
1.1 Shelf-life stability: Data obtained on the LUMIPULSE G1200 System by measuring the Lumipulse G E--III Calibrators (3 Lots) and samples in replicates of 2 using Lumipulse G E2-III Immunoreaction Cartridges (3 Lots) stored at 10°C after 0, 1, 2, 4, 6, 9, 10, 13, 16 and 19 months.
Sensitivity: Lumipulse G E2-III Calibrator 1 and Lumipulse G E2-III Calibrator 3 were measured in duplicate at each test point and the luminescence ratio (Lumipulse G E2-III Calibrator 1/ Lumipulse G E 2-11 Calibrator 3) were calculated. Results met criterion of ratio >=10.
Accuracy: 3 serum samples (215.9 - 1530.2 pg/mL) were tested in replicates of 6 measurements at each time point, and the variation of ratios against the assigned values were calculated. Results met criterion within ± 20% for each replicate.
Reproducibility: 3 serum samples (215.9 - 1530.2 pg/mL) were tested in replicates of 6 measurements, and CVs of measured values at each time point were calculated. Results met criterion of 10% CV or less for each sample.
Key Results: All long-term stability performance up to 18 months met the criteria. Shelf life of Lumipulse G E2-III Calibrators stored at 2-10°C for 19 months was confirmed.
1.2 Transport Simulation (Studies conducted at Fujirebio, Inc. (Tokyo, Japan)): Calibrators packed for overseas transportation were examined in terms of temperature. Stored in conditions: 37 °C 48±2 hours → -20 °C 48±2 hours → 30 °C 96±4 hours → 4 °C 24±2 hours. Performance analysis calculated sensitivity and accuracy.
Sensitivity: Luminescence ratio (E2 calibrator 1 / E2 calibrator 6) was calculated. Criterion: ratio >=10. Result: 38-39, met criteria.
Accuracy: Variation for each calibrator calculated using ratio of measured values (n=1) against assigned values. Criterion: ratios within 100±20%. Result: 98-109%, met criteria.
Key Results: All stability criteria for transport simulation tests were met. Temperature stress had no impact on Lumipulse G E2-III.
2.1 Real Time (Intended Storage) Stability (Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)): On-going study. E-III calibrators stored at 2-10°C, tested in duplicate at specified intervals over shelf life up to planned shelf life plus one month (19 months). Calculated based on percent difference for panels at each time point compared to Time Point 0. Testing continues until data supports 18 months claim.
2.2 Transport Simulation Stability Study (Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)): Calibrators examined in terms of temperature. Stored in conditions: 37 °C 24±2 hours → 25 °C 24±2 hours → -20 °C 24±2 hours → 6 °C 24±2 hours. After each stress, moved to next cycle temp. Visual inspection performed after all cycles, then stored at 2-10ºC. Stressed ICs and Calibrators tested within 3 calendar days after completion of cycles. Calibrators tested in duplicate, controls in replicates of 1, and panels in replicates of 3. Study ongoing.
2.3 Open-vial (In-Use) Stability (Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)): On-going study (included in real-time stability study). Calibrators stored at 2-10℃, all 3 opened and closed at start. Tested in duplicate at specified intervals over shelf life up to planned shelf life plus one month (19 months). Calculated based on percent difference for panels at each time point compared to Time Point 0. At Month 6, immunoreaction cartridges and calibrators determined stable at intended storage conditions for up to 6 Months for all 3 lots. Study ongoing. Testing continues until data supports 18 months claim.
d. Detection limit: Not applicable.
e. Analytical specificity: Not applicable.
f. Assay cut-off: Not applicable.
2. Comparison studies:
a. Method Comparison Not applicable.
b. Method Comparison Not applicable.
c. Matrix Comparison Not applicable.
3. Clinical studies:
a. Clinical sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data: Not applicable
4. Clinical cut-off: Not applicable.
5. Expected values/Reference range: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Shelf-life stability:
Sensitivity: Luminescence ratio >=10.
Accuracy: Variation of ratios against assigned values within ± 20%.
Reproducibility: CV of measured values 10% or less.
Transport Simulation (Studies conducted at Fujirebio, Inc. (Tokyo, Japan)):
Sensitivity: Luminescence ratio >=10.
Accuracy: Ratios within 100±20%.
Predicate Device(s)
K142021 Roche Diagnostics Elecsys Estradiol III CalSet
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016
FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN MANAGER, REGULATORY AFFAIRS 201 GREAT VALLEY PARKWAY MALVERN PA 19355
Re: K163053
Trade/Device Name: Lumipulse® G E2-III Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: October 31, 2016 Received: November 1, 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.
Katherine Serrano -S
For : 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) K163053
Device Name
Lumipulse® G E2-III Calibrators
Indications for Use (Describe)
Lumipulse & E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G E2-III 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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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, featuring blue and white shapes, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font, while "Diagnostics, Inc." is in a smaller font below it.
Section 5 510(k) SUMMARY
Lumipulse® G E2-III Calibrators
- November 23, 2016 Date:
- Submitter: Fujirebio Diagnostics, Inc. 201 Great Vallev Parkwav Malvern, PA 19355
- Contact Person: Stacey Dolan Manager, Regulatory Affairs Phone: (610) 240-3843 Fax: (610) 240-3803 Email: dolans@fdi.com
- Device Name: Lumipulse G E2-III Calibrators Common Name: Estradiol Classification: Class II JIT 75. Clinical Chemistry 21 CFR § 862.1150
- Predicate Device: K142021 Roche Diagnostics Elecsys Estradiol 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:
The Lumipulse G E2-III Calibrator kit contains 3 bottles (1.5mL each) of Lumipulse G E2-III Calibrators 1, 2 and 3. Calibrators 1 – 3 contain estradiol in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Lumipulse G E2-III Calibrators CAL 233849. Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.
CAL 1 E2 calibrator 1 (1 × 1.5 mL)
E₂ calibrator 2 (1 x 1.5 mL) CAL 2
- CAL 3 E2 calibrator 3 (1 × 1.5 mL)
*Contains 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
The calibrator values vary for each lot. The actual values are printed on the calibration card included in the kit.
4
Image /page/4/Picture/1 description: The image is a 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 is the company name, "FUJIREBIO" in large, blue, bold letters. Below the company name is the text "Diagnostics, Inc." in a smaller, black font.
Device Intended Use:
Lumipulse G E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G E2-III on the LUMIPULSE® G System.
Device Indications for Use:
Same as Intended Use
Substantial Equivalence:
Comparison between the Lumipulse G E2-III Calibrators and Elecsys Estradiol III CalSet Similaritios and Difforon
| Similarities and Differences | ||
|---|---|---|
| Parameter | Lumipulse G | |
| E2-III Calibrators | ||
| (Proposed Device) | Elecsys Estradiol III | |
| CalSet (Predicate Device) | ||
| K142021 | ||
| Intended Use | Lumipulse G E2-III Calibrators are | |
| for in vitro diagnostic use in the | ||
| calibration of Lumipulse G E2-III | ||
| (Estradiol) on the LUMIPULSE® G | ||
| System. | Estradiol III CalSet is used | |
| for calibrating the | ||
| quantitative Elecsys | ||
| Estradiol III assay on the | ||
| Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Instrument System | LUMIPULSE® G System | Elecsys and cobas e |
| Analyte | Estradiol | same |
| Matrix | Tris buffer with bovine stabilizer | Human serum |
| Levels | • 3 levels | |
| 19 - 2000 pg/mL | ||
| • Concentrations are lot specific | • 2 levels | |
| 20 - 2000 pg/mL | ||
| • Concentrations are lot specific | ||
| Standardization/Traceability | The calibrators for use with | |
| Lumipulse G E2-III are prepared | ||
| gravimetrically and are traceable | ||
| to BCR-577 by IRMM (Institute for | ||
| Reference Materials and | ||
| Measurements) and verified | ||
| against ID-GC/MS. | ||
| Stability | Store at 2 - 10 °C until expiration | |
| date | Store at 2 - 8 °C until | |
| expiration date | ||
| Form | Liquid; ready to use | Lyophilized |
Performance Characteristics
Data were generated using the LUMIPULSE® G1200 System.
-
- Analytical performance:
- a. Precision/Reproducibility: Not applicable.
5
Image /page/5/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 blue text. The graphic is a combination of blue and green shapes, with a white teardrop shape in the center. The text "FUJIREBIO" is in large, bold, blue letters, and "Diagnostics, Inc." is in smaller, black letters below it.
- b. Linearity/assay reportable range: Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability
The calibrators for use with Lumipulse G E2-III are prepared gravimetrically and are traceable to BCR-577 by IRMM (Institute for Reference Materials and Measurements) and verified against ID-GC/MS.
Value Assignment
The 2000 pg/mL Calibrator (CAL3), the 0 pg/mL Calibrator (CAL1) and the Calibrator2 (approximately 50 pg/mL) are prepared by the following method. Teritary calibrator used ESTRADIOL from Pharmaceutical and Medical Device Regulatory Science Society of Japan. The E solution is prepared by dissolving ESTRADIOL in ethanol. The E 1st stock solution is prepared by spiking the E solution into 2-amino-2-hydroxymethyl-1,3propandiol-based buffer. A 200 stock solution (working stock solution) is prepared by spiking the E2 1st stock solution into 2-amino-2-hydroxymethyl-1,3-propandiol-based buffer.CAL3 is prepared gravimetrically from the working stock solution to achieve the desired value 2000 pg/mL, and is rate-matched to the secondary calibrators based on the measurement in the Lumipulse G E -- III assay and adjusted if necessary. Dilutions are made gravimetrically using one part of CAL3 and 2-amino-2-hydroxymethyl-1.3propandiol-based buffer to obtain CAL2. CAL3 and CAL1 are rate-matched to the secondary calibrators based on the measurement in the Lumipulse G E2-III assay and adjusted if necessary. The tertiary calibrators are measured in 10 replicates, 3 runs on LUMIPULSE G instruments. The acceptable rate mean ratio of CAL3 or CAL1 is 0.95 -1.05. The mean ratio is the mean counts of each tertiary calibrator (10 replicates) to the respective secondary calibrators (10 replicates). For CAL2 value assignment, CAL2 and secondary calibrators are measured in 10 replicates, 3 runs on LUMIPULSE G instruments. The measurement value of CAL2 is calculated from the calibration curve of secondary calibrators in each run using the average of 3 runs for the assigned value. The acceptable value of CAL2 is -20% - +20% range of 50 pg/mL, see table below.
Calibrator 2 is value assigned and therefore values vary for each lot. The actual values are printed on the calibration card included in the kit.
Target values and target ranges for Calibrator 2 are listed in the table below.
| Calibrator | Target Values (pg/mL) | Target Range (pg/mL) |
|---|---|---|
| Cal2 | 50 | 40-60 |
Calibrators 1 and 3 are rate matched and have assigned values of 0 pg/mL for Calibrator 1 and 2000 pg/mL for Calibrator 3. The level of uncertainty around Calibrator 3 is 5%.
6
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 combination of blue and green shapes, with a white teardrop shape in the center. The company name is written in blue, with "FUJIREBIO" in a larger font size than "Diagnostics, Inc."
Stability
Studies conducted at Fujirebio, Inc. (Tokyo, Japan) 1.
1.1 Shelf-life stability
The shelf-life stability data were obtained on the LUMIPULSE G1200 System by measuring the Lumipulse G E--III Calibrators (3 Lots) and samples in replicates of 2 using Lumipulse G E2-III Immunoreaction Cartridges (3 Lots) that were stored at 10°C after 0, 1, 2, 4, 6, 9, 10, 13, 16 and 19 months. Sensitivity, accuracy and reproducibility were calculated.
Sensitivity
Lumipulse G E2-III Calibrator 1 and Lumipulse G E2-III Calibrator 3 were measured in duplicate at each test point and the luminescence ratio (Lumipulse G E2-III Calibrator 1/ Lumipulse G E 2-11 Calibrator 3) were calculated. The results met the criterion of the ratio of ≥10.
Accuracy
3 serum samples ranged (215.9 - 1530.2 pg/mL) were tested in replicates of 6, 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 (215.9 - 1530.2 pg/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 18 months met the criteria. Therefore, the shelf life of the Lumipulse G E2-III Calibrators stored at 2-10°C for 19 months was confirmed.
Shelf life
The shelf life for Lumipulse G E2-III Calibrators is 18 months at 2-10°C.
1.2 Transport Simulation
The transport simulation stability of the Lumipulse G E--III 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 °C 48±2 hours → 30 °C 96±4 hours → 4 °C 24±2 hours. To determine the impact of temperature on the Lumipulse G E -- III Calibrators, a performance analysis was conducted.
The performance analysis calculated sensitivity and accuracy. For sensitivity, the luminescence ratio (E2 calibrator 1 / E2 calibrator 6) was calculated. The criterion was a ratio greater than or equal to10. For accuracy, the variation for each calibrator was
7
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, featuring blue and green shapes, and the company name on the right. The company name is written in a bold, blue font, with "FUJIREBIO" on the top line and "Diagnostics, Inc." on the bottom line.
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 38-39 and met the criteria of ≥ 10. The accuracy ranged from 98-109% 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 E2-III.
2. Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
2.1 Real Time (Intended Storage) Stability
Real-time (Intended Storage) stability is being evaluated as follows: In the on-going real-time stability study, the Lumipulse G E-III calibrators are stored at 2-10°C. The E2-III calibrators are tested in duplicate at specified intervals over the shelf life of the device up to the planned shelf life plus one month (19 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 testing will continue with this stability protocol until data to support a claim of 18 months is achieved.
2.2 Transport Simulation Stability Study
Transport simulation of the Lumipulse G E2-III 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 E -- III Calibrators, a performance analysis was conducted.
After each stress condition, all Lumipulse G E2-III ICs and Lumipulse G E2-III Calibrators were moved to the next cycle temperature. After all cycles were complete, a visual inspection was performed and the Lumipulse G E2-III calibrators were stored at the intended storage condition of 2-10ºC. Stressed Lumipulse G E-III IC's and Calibrators were tested within 3 calendar days after the completion of all cycles. Calibrators were tested in duplicate, controls in replicates of 1 and panels in replicates of 3.
Study Initiation was the first time point for testing; therefore no percent difference was calculated for the panel set as there were no other time points to compare against. This stability study is still ongoing.
Transport Conditions
Lumipulse G E2-III Calibrators are shipped at 2-10°C.
8
Image /page/8/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 white shapes, with a droplet-like form in the center. The text "FUJIREBIO" is in a bold, blue sans-serif font, and "Diagnostics, Inc." is in a smaller, gray sans-serif font below it.
2.3 Open-vial (In-Use) Stability
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 E2-III calibrators are stored at 2-10℃ and all 3 calibrators were opened and closed at the start of the study (Time Point). The E2-III calibrators are tested in duplicate at specified intervals over the shelf life of the device up to the planned shelf life plus one month (19 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).
For all 3 lots, Time Point 2 (Month 6) was the second time point for testing. At this time, the Lumipulse G E2-III immunoreaction cartridges and calibrators were determined to be stable at the intended storage conditions for up to 6 Months for all 3 lots. This stability study is still ongoing.
The testing will continue with this stability protocol until data to support a claim of 18 months is achieved.
- d. Detection limit: Not applicable.
- e. Analytical specificity: Not applicable.
- f. Assay cut-off: Not applicable.
-
- Comparison studies:
- a. Method Comparison Not applicable.
- b. Method Comparison Not applicable.
- c. Matrix Comparison Not applicable.
-
- Clinical studies:
- a. Clinical sensitivity: Not applicable
- b. Clinical specificity: Not applicable
9
Image /page/9/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 blue text. The graphic is a combination of blue and green shapes, with a white teardrop shape in the center. The text "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc."
- Other clinical supportive data (when a. and b. are not applicable): C. Not applicable
-
- Clinical cut-off: Not applicable.
-
- Expected values/Reference range: Not applicable.
Proposed Labeling
The labeling 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
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.