The Lumipulse® G LH Calibrator kit contains 2 bottles (1.5mL each) of Lumipulse® G LH Calibrators 1 and 2. Calibrators 1 and 2 contain luteinizing hormone (LH) in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Lumipulse® G LH Calibrators CAL 230916, Liquid 1x2 concentrations

Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately.

CAL 1 0 mlU/mL LH calibrator (1 x 1.5 mL) CAL 2 250 mIU/mL LH calibrator (1 x 1.5 mL) *Contains luteinizing hormone (LH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide

The Lumipulse® G LH calibrator set is designed specifically for use on the LUMIPULSE® G System which has been previously cleared under K142895.

AI/ML Overview

The provided text describes the Lumipulse® G LH Calibrators device, focusing on its regulatory approval, intended use, and performance characteristics, particularly its stability. This device is a calibrator, not a diagnostic or AI-powered imaging device, therefore many of the requested elements for AI/imaging studies are not applicable.

Here's the information extracted and organized based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a calibrator, and its performance is primarily assessed through stability studies and traceability.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Shelf-Life Stability	Sensitivity: Ratio of 20 mIU/mL LH luminescence to 0 mIU/mL LH luminescence ≥ 20. Accuracy: Ratios of measured values to pre-assigned values should be within 100 +/- 20% for each replicate. Within-run Reproducibility: CV ≤ 10% for each sample.	Met criteria for up to 13 months at 10°C (demonstrating stability for the claimed 12 months shelf-life). Specific sensitivity ratio and accuracy ranges were met. The CV for precision was ≤ 10%.
Real-Time Intended Storage Stability (Malvern, PA study)	Mean concentration of each panel within ±10% mean concentration at Study Initiation. % CV value of each panel ≤ 10%. (Goal: 12 months)	Lumipulse G LH Calibrators were determined to be stable at intended storage conditions for up to 6 months for all 3 lots (Time Point 2 testing). Study is ongoing to support the 12-month claim.
Transport Simulation Stability (Temperature Change - Tokyo, Japan study)	Visual Inspection: Cleared criteria. Sensitivity: Ratio of 2 mlU/mL to 0 mIU/mL LH luminescence ≥ 21.Accuracy: Each value after stress within 100 +/- 20% of reference value for control and serum samples.	Visual inspection cleared. Sensitivity test (ratio ≥ 21) met criteria. Accuracy test (values within 100 +/- 20% of reference) met criteria.
Transport Simulation Stability (Temperature - Malvern, PA study)	%CV ≤ 10% for all transport conditions tested at study initiation.	Met acceptance criteria of %CV ≤ 10% for all transport conditions tested at study initiation. Study is ongoing.
Value Assignment	Acceptable rate mean ratio for 3 runs (secondary calibrator to Lumipulse G LH calibrator) 0.95 – 1.05.	Achieved (implied by the process description and overall substantial equivalence finding). Specific values are not reported but the methodology is described.
Target Values/Ranges	Level 1: 0 mIU/mL LH Level 2: 250 mIU/mL LH (Target Range: 238-262 mIU/mL)	These are the stated target values and ranges for the calibrators themselves, which the device is designed to embody. The performance studies confirm that assigned values and stability maintain these specifications.

2. Sample Size and Data Provenance

Test Set (Stability Studies):
- Shelf-Life Stability (Tokyo, Japan): Three lots of Lumipulse G LH Calibrators. Tested at Month 0, 3, 7, and 13.
  - Sensitivity: 0 and 20 mIU/mL LH solutions in replicates of 3.
  - Accuracy: 3 samples (5,850-162,217 mIU/mL) in replicates of 3.
  - Within-run Reproducibility: 4 samples (5.850-162.217 mIU/mL) in replicates of 6.
- Transport Simulation Stability (Tokyo, Japan): Not explicitly stated as "samples" but implied for a single set of Lumipulse G LH Calibrators and other components.
  - Sensitivity: 0 and 2 mlU/mL LH solutions (replicates not specified but implied).
  - Accuracy: 3 control samples (4.1-55.6 mlU/mL) in replicates of 1, and 4 serum samples (11.1-294.0 mlU/mL) in replicates of 2.
- Real-Time (Intended Storage and Open Use) Stability (Malvern, PA): Three lots of Lumipulse G LH Calibrators. Tested in duplicate at specified intervals up to 13 months. The number of "panels" is not specified but implied to contain various concentrations.
- Transport Simulation Stability (Malvern, PA): Not explicitly stated, implied to be samples from the calibrator lots. Calibrators tested in duplicate, controls in replicates of 1, and panels in replicates of 3.
Data Provenance:
- Tokyo, Japan: Studies conducted at Fujirebio, Inc. with a predecessor instrument (LUMIPULSE Forte (f)) confirmed to have agreement with LUMIPULSE G1200. This is retrospective data for the "predecessor instrument," but it's used to support the current device.
- Malvern, PA, USA: Studies conducted at Fujirebio Diagnostics, Inc. on the LUMIPULSE G1200 System. These are ongoing real-time studies, so they are prospective for the current device's claims.

The document does not specify a separate "test set" in the context of an algorithm's performance against ground truth, as it's a calibrator.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is a medical device (calibrator) whose performance is evaluated through analytical studies, not expert review of images or clinical cases. The "ground truth" for calibrators is their assigned value and traceability to international standards.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically used in clinical trials or diagnostic studies for resolving discrepancies in expert opinions. Performance here is based on quantitative analytical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for diagnostic imaging interpretation, assessing the impact of a device on human expert performance. This device is a calibrator for an in-vitro diagnostic assay.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical calibrator used within an assay system, not a standalone algorithm. Its performance is intrinsically linked to its use in the LUMIPULSE G System.

7. Type of Ground Truth Used

The ground truth for the Lumipulse® G LH Calibrators is established through:

Traceability to International Standards: The calibrators are traceable to the 2nd International Standard, 1988 (code: 80/552) provided by the National Institute for Biological Standards and Control (NIBSC).
Gravimetric Preparation and Value Assignment: Calibrators are prepared gravimetrically, and their values are assigned based on measurement against secondary calibrators, ensuring accuracy against the fundamental international standard.

8. Sample Size for the Training Set

Not applicable. This device is a calibrator, not an AI algorithm that undergoes "training." Its manufacturing and validation process (including stability and value assignment) are based on established analytical chemistry principles.

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

Not applicable (as above). The concept of a "training set" and "ground truth establishment" pertains to machine learning algorithms. For a calibrator, its "truth" is its certified concentration and its traceability to a universally accepted standard through rigorous analytical testing.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

FUJIREBIO DIAGNOSTICS, INC DIANA DICKSON DIRECTOR, CLINICAL AND REGULATORY SCIENCE 201 GREAT VALLEY PARKWAY MALVERN PA 19355

January 12, 2017

Re: K163521

Trade/Device Name: Lumipulse® G LH Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: December 14, 2016 Received: December 15, 2016

Dear Diana Dickson:

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.

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

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Indications for Use

510(k) Number (if known)

K163521

Device Name

Lumipulse® GLH Calibrators

Indications for Use (Describe)

Lumipulse GLH Calibrators are for in vitro diagnostic use in the calibration of Lumipulse GLH on the LUMIPULSE G System.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(k) SUMMARY

Lumipulse® G LH Calibrators

Date:	January 6, 2016
-------	-----------------

510(k) Number: K163521
Submitter: Fujirebio Diagnostics, Inc. 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

Device Name:	Lumipulse® G LH Calibrators
Common Name:	Human Luteinizing Hormone
Classification:	Class IIJIT75, Clinical Chemistry21 CFR § 862.1150
Predicate Device:	K111023Abbott Laboratories

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.

Abbott ARCHITECT® LH Calibrators

Device Description:

Lumipulse® G LH Calibrators CAL 230916, Liquid 1x2 concentrations

Each calibrator kit contains one bottle each of Calibrators 1 – 2. 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 element on the left, followed by the company name in blue text. The graphic element is a combination of blue and green shapes, with a white teardrop shape in the center. The text "FUJIREBIO" is in a bold, sans-serif font, and "Diagnostics, Inc." is in a smaller font below it.

The Lumipulse® G LH calibrator set is designed specifically for use on the LUMIPULSE® G System which has been previously cleared under K142895.

Device Name:

Lumipulse G LH Calibrators

Device Intended Use:

Lumipulse G LH Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G LH on the LUMIPULSE G System.

Device Indications for Use:

Same as Intended Use

Substantial Equivalence:

Comparison between the Lumipulse G LH Calibrators and Abbott ARCHITECT LH Calibrators

Similarities and Differences
Parameter	Lumipulse GLH Calibrators(Proposed Device)	Abbott ARCHITECT LHCalibrators (PredicateDevice)K111023
Intended Use	Lumipulse G LH Calibrators arefor in vitro diagnostic use in thecalibration of Lumipulse G LH onthe LUMIPULSE G System.	For the calibration of theARCHITECT i Systemwhen used for thequantitative determinationof human luteinizinghormone (LH) in humanserum and plasma.
Analyte	Luteinizing hormone	same
Composition	• Calibrators 1-2: Luteinizinghormone (from human pituitary)• Calibrators 1-2: Diluent: Trisbuffer with protein (bovine) andchemical stabilizers• Calibrators 1-2: Preservative:Sodium azide	• Calibrators B-F:Luteinizing hormone(from human pituitary)• Calibrator A-F: Diluent:Phosphate buffer withprotein stabilizers(bovine)• Calibrators A-F:Preservatives: ProClin300, ProClin 950
LH Calibrators	• 2 levels• 0 and 250 mlU/mL humanluteinizing hormone	• 6 levels• 0.00, 1.00, 3.50, 15.00,50.00, 250.00 mlU/mLhuman luteinizinghormone
Standardization/Traceability	Calibration of the LUMIPULSE GLH is traceable to in-housereference calibrators, whose	The calibrators arereferenced to the WorldHealth Organization

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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 includes a blue and white abstract shape, with vertical green lines next to it. The text "FUJIREBIO" is in a bold, sans-serif font, with "Diagnostics, Inc." in a smaller font below it.

Similarities and Differences
Parameter	Lumipulse GLH Calibrators(Proposed Device)	Abbott ARCHITECT LHCalibrators (PredicateDevice)K111023
	values have been assigned to the2nd International Standard, 1988(code: 80/552) provided by theNational Institute for BiologicalStandards and Control (NIBSC).	(WHO) LuteinizingHormone (LH) Human,Pituitary 2nd InternationalStandard 80/552.

Performance Characteristics

Data were generated using the LUMIPULSE G1200 System.

1. Analytical performance:
- a. Precision/Reproducibility: Not applicable.
- b. Linearity/assav reportable range: Not applicable.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability

The calibrators for use with Lumipulse G LH are prepared gravimetrically and are traceable to the 200 International Standard, 1988 (code: 80/552) provided by the National Institute for Biological Standards and Control (NIBSC).

Value Assignment

LH Antigen Grade is obtained from CLINIQA. A working stock solution is prepared by dissolving LH antigen in 2-amino-2-hydroxymethyl-1,3-propandiol-based buffer. The working stock solution is assigned a provisional value based on the measurement (6 replicates) using Lumipulse G LH on the LUMIPULSE G system with secondary calibrators. Lumipulse G LH Calibrators 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 250 mlU/mL calibrator value (Lumipulse G LH Calibrator 2) and adding them together gravimetrically. The 0 mlU/mL calibrator (Lumipulse G LH Calibrator 1) only contains the 2-amino-2-hydroxymethyl-1,3propandiol-based buffer. Lumipulse G LH Calibrator 2 is rate-matched to the respective secondary calibrator based on the measurement in Lumipulse G LH and adjusted if necessary. The measurement of Lumipulse G LH calibrators (10 replicates) and secondary calibrators (10 replicates) are performed on three runs on the LUMIPULSE G system. The mean ratio is the mean counts of the secondary calibrator to the respective Lumipulse G LH calibrator. The acceptable rate mean ratio for the 3 runs is 0.95 – 1.05. This solution is stored at 2 to 10°C.

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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, featuring blue and green shapes that resemble a water droplet or a stylized flower. To the right of the graphic, the words "FUJIREBIO" are written in a bold, blue sans-serif font. Below "FUJIREBIO", the words "Diagnostics, Inc." are written in a smaller, black sans-serif font.

Calibrator	Target Values (mIU/mL)	Target Ranges (mIU/mL)
Level 1	0	N/A
Level 2	250	238 - 262

Stability

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 2-10ºC. The sponsor's protocol and acceptance criteria was reviewed and found to be acceptable.

*Note: (The LUMIPULSE f System uses the same Lumipulse G LH Immunoreaction Cartridges and Calibrators as the LUMIPULSE G1200 System).

See Section 14 - Sterilization and Shelf Life for more stability study related data and information.

1. Studies conducted at Fujirebio, Inc. (Tokyo, Japan)

Shelf-Life Stability

Three lots of Lumipulse G LH Calibrators were tested on real-time stability with Lumipulse forte (f), a predecessor instrument of LUMIPULSE G1200. LUMIPULSE f and LUMIPULSE G1200 have a confirmed agreement rate.

Three lots of Lumipulse G LH Calibrators were stored at 10℃ for Month 0, 3, 7 and 13 and tested for sensitivity, accuracy and within-run reproducibility.

The results met the criteria for up to 13 months in the 3 lots of Lumipulse G LH Calibrators. Thus it was demonstrated that the LUMIPULSE G LH Calibrators were stable up to 13 months at 10℃ on the LUMIPULSE f System.

. Regarding the sensitivity, 0 and 20 mIU/mL LH solutions were tested at each test point in replicates of 3 and the ratio of the amount of the luminescence ("20 mIU/mL" /"0 mIU/mL" LH) were calculated. The criterion was 20 or higher in the ratio.
Regarding the accuracy. 3 samples that ranged 5,850-162,217 mlU/mL were tested . in replicates of 3 at each time point and the ratios of the measured values to the preassigned values were confirmed. The criterion was that the ratios should be within 100 +/- 20% for each replicate.
. Regarding within-run reproducibility, 4 samples that ranged 5.850-162.217 mlU/mL were tested in replicates of 6 at each time point. The criterion for the precision was 10% or lower in the CV for each sample.

Shelf-Life

The shelf life of Lumipulse G LH Calibrators is 12 months at 2 - 10℃.

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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, followed by the company name in blue text. The graphic appears to be a combination of shapes and lines, possibly representing water droplets or a stylized flower. The text "FUJIREBIO" is in a larger, bolder font, while "Diagnostics, Inc." is in a smaller font below.

Transport Conditions

The transport simulation stability of Lumipulse G LH packed for overseas transport was examined in terms of temperature change.

Temperature change: The Lumipulse G LH Immunoreaction Cartridges, Lumipulse G LH Calibrators, LUMIPULSE G Substrate, LUMIPULSE G Wash Solution and LUMIPULSE G Specimen Diluent 1 were subjected to the following temperature stress: 37 °C 48 +/- 2 hours -> -20 °C 48 +/- 2 hours -> 30 °C 96 +/- 4 hours -> 4 °C 24 +/- 2 hours, according to the stress condition in the internal protocol. Then a visual inspection was carried out for the Lumipulse G LH Cartridges and it was confirmed that they cleared the criteria. Also a sensitivity test and accuracy test were conducted and compared with the intended condition (control). The sensitivity testing was conducted with 0 and 2 mlU/mL LH solutions and the criterion was the ratio of the amount of luminescence ("2 mlU/mL" / "0 mIU/mL" LH) to be 21 or higher. The accuracy testing was conducted with 3 control samples (concentration: 4.1-55.6 mlU/mL with LUMIPULSE G1200) and 4 serum samples (concentration: 11.1-294.0 mlU/mL with LUMIPULSE G1200) in replicates of 1 for control samples and 2 for the serum samples with LUMIPULSE G1200, and the criteria of each value after the stress were 100 +/- 20% of the reference value of each serum sample.

The results of the sensitivity test and accuracy met the criteria. Therefore, the temperature change described above did not affect the performance of Lumipulse G LH using the LUMIPULSE G1200 System.

Lumipulse G LH Calibrators are shipped at 2-10°C.

1. Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)

Real Time (Intended Storage and Open Use)

Real-time (Intended Storage and open use) stability is being evaluated as follows: In the on-going real-time stability study, the Lumipulse G LH calibrators are stored at 2-10°C. The LH calibrators are tested on one Lumipulse G1200 instrument in duplicate at specified intervals 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. The % CV value of each panel at each time point must be ≤ 10%. For all 3 lots, Time Point 2 (6 months) was the second time point for testing. The Lumipulse G LH Calibrators were determined to be stable at the intended storage conditions for up to 6 months for all 3 lots.

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/8/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized symbol on the left and the company name on the right. The symbol 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."

Transport Simulation Stability Study

Transport simulation of the Lumipulse G LH 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 LH Calibrators, a performance analysis was conducted.

After each stress condition, all Lumipulse G LH ICs and Lumipulse G LH Calibrators were moved to the next cycle temperature. After all cycles were complete, a visual inspection was performed and the Lumipulse G LH calibrators were stored at the intended storage condition of 2-10°C. Stressed Lumipulse G LH 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.

At study initiation, the assay met the acceptance criteria of %CV ≤10% for all transport conditions tested. This stability study is still ongoing.

Transport Conditions Lumipulse G LH Calibrators are shipped at 2-10°C.

d. Detection limit: Not applicable.
e. Analytical specificity: Not applicable
f. Assay cut-off: Not applicable.
1. Comparison studies:
- a. Method Comparison with predicate device: Not applicable.
- b. Method Comparison Not applicable.
- c. Matrix Comparison Not applicable.
1. Clinical studies:
- a. Clinical sensitivity: Not applicable
- b. Clinical specificity: Not applicable

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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 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 text "FUJIREBIO" is in blue, and "Diagnostics, Inc." is in a smaller font size below the company name.

Other clinical supportive data (when a. and b. are not applicable): C. Not applicable
1. Clinical cut-off: Not applicable.
1. 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.

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.