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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Lumipulse® G FSH-N Calibrators, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Long-Term Stability (Sensitivity)	Luminescence ratio (2 mIU/mL / 0 mIU/mL FSH) ≥ 20	Results met the criterion of the ratio of ≥ 20.
Long-Term Stability (Accuracy)	Variation of ratios against assigned values within ± 20% for each replicate (for 3 serum samples ranged 10.5 - 185.0 mIU/mL)	Results met the criterion within ± 20% for each replicate.
Long-Term Stability (Reproducibility)	CV ≤ 10% for each sample (for 3 serum samples ranged 10.5 - 185.0 mIU/mL)	Results met the criterion of 10% CV or less for each sample.
Real-Time (Intended Storage) Stability	Mean concentration of each panel from each time point within ± 10% mean concentration at Study Initiation.	For all 3 lots, Time Point 2 (month 6) met the acceptance criteria. (Study ongoing)
Open-Vial (in-use) Stability	Mean concentration of each panel from each time point within ± 10% mean concentration at Study Initiation.	For all 3 lots, Time Point 2 (month 6) met the acceptance criteria. (Study ongoing)
Transport Simulation (Temperature) - Tokyo, Japan (Sensitivity)	Luminescence ratio (FSH-N calibrator 2 / FSH-N calibrator 1) ≥ 10	The luminescence ratio was 90 under control conditions and 87 under stress conditions, meeting the criteria of ≥ 10.
Transport Simulation (Temperature) - Tokyo, Japan (Accuracy)	Ratios of measured values (n=1) against assigned values within 100 ± 20%	The accuracy ranged from 99-108% under control and 96-104% under stress, meeting the criteria of 100 ± 20%.
Transport Simulation (Temperature) - Malvern, PA	%CV ≤ 10% for all transport conditions tested (at study initiation)	At study initiation, the assay met the acceptance criteria of %CV ≤ 10% for all transport conditions tested. (Study ongoing)
Value Assignment (Mean Ratio)	Mean ratio of secondary calibrator (10 replicates) to tertiary calibrator (10 replicates) between 0.97 - 1.03	Not explicitly stated if this was the reported device performance, but the process describes how the tertiary calibrator is "rate-matched" and "adjusted if necessary" to achieve this.

2. Sample Size Used for the Test Set and Data Provenance

Long-Term Stability (Tokyo, Japan):
- 3 Lots of Lumipulse G FSH Calibrators.
- 3 Lots of Lumipulse G FSH Immunoreaction Cartridges.
- FSH solutions of 0 and 2 mIU/mL were measured in replicates of 3 at each test point.
- 3 serum samples (ranged 10.5 - 185.0 mIU/mL) were tested in replicates of 3 for accuracy and replicates of 6 for reproducibility.
- Provenance: Fujirebio, Inc. (Tokyo, Japan); data stored at 10°C, measured at 0, 3, 7, and 13 months.
Real-Time (Intended Storage) Stability (Malvern, PA):
- 3 Lots of Lumipulse G FSH-N calibrators.
- Tested in duplicate at Month 0, 6, 12, and 13.
- Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.
Open-Vial (in-use) Stability (Malvern, PA):
- 3 Lots of Lumipulse G FSH-N calibrators.
- Tested in duplicate at Month 0, 6, 12, and 13.
- Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.
Transport Simulation (Tokyo, Japan):
- Not explicitly stated, but the study implies testing of the Lumipulse G FSH-N Calibrators.
- Replicates: Luminescence ratio (FSH-N calibrator 2 / FSH-N calibrator 1) for sensitivity, and single measurements (n=1) for accuracy.
- Provenance: Fujirebio, Inc. (Tokyo, Japan).
Transport Simulation (Malvern, PA):
- Lumipulse G FSH-N Calibrators and Lumipulse G FSH-N ICs.
- Calibrators were tested in duplicate, controls in replicates of 1, and panels in replicates of 3.
- Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is a calibrator, not a diagnostic device requiring human interpretation of results. Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" or reference values are established through metrological traceability and value assignment protocols.

4. Adjudication Method for the Test Set

Not applicable, as this is related to human interpretation and not directly relevant for a calibrator's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This document describes performance of a calibrator.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance characteristics described (stability, traceability, value assignment, transport simulation) are all standalone performance evaluations of the calibrator product itself. The calibrator's ability to provide accurate and stable calibration values is assessed independently.

7. The Type of Ground Truth Used

The ground truth for the calibrators is established through a combination of:

Metrological Traceability: Calibrators are traceable to the 1st International Standard, 1997 (code 92/510) provided by the National Institute for Biological Standards and Control (NIBSC).
Gravimetric Preparation: Calibrators are prepared gravimetrically.
Value Assignment Protocol: Involves provisional value assignment based on measurements using secondary calibrators, then rate-matching and adjusting tertiary calibrators to secondary calibrators.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of an AI/machine learning algorithm is not applicable here. This device is a chemical calibrator for an immunoassay system, not an AI or algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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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.

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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)

K163534

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 4

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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:

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:

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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 GFSH-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 addedhuman FSH
Levels	Two levels	Two levels
Intended Use	Lumipulse G FSH-N Calibratorsare for in vitro diagnostic use inthe calibration of Lumipulse GFSH-N on the LUMIPULSE GSystem.	Elecsys FSH II CalSet usedfor calibrating the quantitativeElecsys FSH assay on theElecsys and cobas eimmunoassay analyzers.
Stability	Stable at 2-10ºC until expired	Stable at 2-8ºC until expired

Performance Characteristics

Data were generated using the LUMIPULSE G1200 System.

1. 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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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 ℃.

1. 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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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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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.

Regulation Number and Section

§ 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.