(27 days)
Not Found
No
The document describes calibrators for an in vitro diagnostic test, focusing on chemical composition, stability, and performance characteristics related to calibration. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an in vitro diagnostic calibrator used for the calibration of an assay that measures prolactin levels. It is not used to treat or diagnose a disease or condition in a patient.
No
The device is a calibrator kit used for in vitro diagnostic (IVD) purposes, specifically for the calibration of a diagnostic device (LUMIPULSE G System) that measures prolactin. It is not itself a diagnostic device, but rather a component used to ensure the accuracy and reliability of diagnostic testing.
No
The device is a calibrator kit containing liquid solutions with specific concentrations of prolactin. This is a physical product used in in vitro diagnostic testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Lumipulse G Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Prolactin on the LUMIPULSE G System."
This statement clearly indicates that the device is intended to be used outside of the body to diagnose or aid in the diagnosis of a condition, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Lumipulse G Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Prolactin on the LUMIPULSE G System.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Lumipulse G Prolactin Calibrator kit contains 2 bottles (1,5 mL each) of Lumipulse G Prolactin Calibrators 1 and 2. Calibrator 2 contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Lumipulse® G Prolactin Calibrators CAL 230954, Liquid 1x2 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately.
CAL 1 0 ng/mL Prolactin calibrator (1 x 1.5 mL)
CAL 2 400 ng/mL Prolactin calibrator (1 x 1.5 mL)
Contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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 Prolactin are prepared gravimetrically and are traceable to the 3th International Standard, 1988 (code: 84/500) provided by the National Institute for Biological Standards and Control (NIBSC).
Value Assignment
Prolactin Antigen Grade is obtained from CLINIQA. The working stock solution is prepared by dissolving Prolactin antigen in 2-amino-2-hydroxymethyl-1,3propandiol-based buffer. The working stock solution is assigned a provision value based on the measurement using LUMIPULSE G Prolactin on the LUMIPULSE G System with secondary calibrators. Lumipulse G Prolactin Calibrators are made by calculating the amount of working stock solution and 2-amino-2-hydroxymethyl-1,3propandiol-based buffer required to achieve the desired 400 ng/mL calibrator value (Lumipulse G Prolactin Calibrator 2) and adding them together gravimetrically. The 0 ng/mL Calibrator (Lumipulse G Prolactin Calibrator 1) only contains the 2-amino-2hydroxymethyl-1,3-propandiol-based buffer. Lumipulse G Prolactin Calibrator 2 is rate-matched to the respective secondary calibrator based on the measurement in Lumipulse G Prolactin and adjusted if necessary. The measurement of Lumipulse G Prolactin Calibrators (10 replicates) and secondary calibrators (10 replicates) are performed on 3 runs using the LUMIPULSE G System. The mean ratio is the mean counts of the secondary calibrator to the respective Lumipulse G Prolactin Calibrator. The acceptable rate mean ratio is 0.95 - 1.05. This solution is stored at 2 to 10 °C.
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 accelerated 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.
Studies conducted at Fujirebio, Inc. (Tokyo, Japan)
1.1 Long-term stability
The long-term stability data were obtained on the LUMIPULSE G System by measuring the Prolactin calibrators and samples for 3 lots of reagents that were stored at 10°C for 0, 3, 7, and 13 months. Sensitivity, specificity and reproducibility were calculated.
The results of sensitivity, accuracy and reproducibility confirmed that in a 13-month test, standards were met and the product passed. Therefore, the shelf life of the Lumipulse G Prolactin Calibrators stored at 2-10°C for 12 months was confirmed.
1.2 Transport Simulation
Transportation Testing (Temperature Stress Testing) data were obtained by stressing reagents. calibrator (standard solution), substrate solution, and diluent under the following conditions: 37°C, 48 hours ± 2 hours → -20°C, 48 hours ± 2 hours → 30°C, 96 hours ± 4 hours-> storage conditions (4°C), 24 hours ± 2 hours. Sensitivity, accuracy, and visual inspection were performed.
Visual assessment of 5 items was 0/28 under control conditions and 0/28 under stress conditions, thus meeting the specification. Sensitivity was 162 under control conditions and 171 under stress conditions, in each case meeting the S/N≥51 specification. Accuracy (versus test values) was 95-101% under control conditions and 99-109% under stress conditions, in each case meeting the specification for "within 100 ± 20%." Therefore, the results of sensitivity, accuracy, and visual inspection all met specification.
Studies conducted at Fujirebio Diagnostics, Inc. (Malvern, PA)
2.1 Real Time (Intended Storage) Stability
In the on-going real-time stability study, the Lumipulse G Prolactin calibrators are stored at 2-10 C. The Prolactin calibrators are tested 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).
Time Point 2 (Month 6) was the second time point for testing. The Lumipulse G Prolactin 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.
2.2 Transport Simulation Stability Study
Transport simulation of the Lumipulse G Prolactin 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 ± 10 C 24±2 hours → 6 C ± 4 C 24±2 hours. To determine the impact of temperature on the Lumipulse G prolactin Calibrators, a performance analysis was conducted.
After each stress condition, all Lumipulse G Prolactin ICs and Lumipulse G Prolactin Calibrators were moved to the next cycle temperature. After all cycles were complete, a visual inspection was performed and the Lumipulse G Prolactin calibrators were stored at the intended storage condition of 2-10°C. Stressed Lumipulse G Prolactin 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. The stability study is ongoing.
Shelf life
The shelf life for Lumipulse G Prolactin Calibrators is 12 months at 2-10°C, based on the longterm stability study conducted at Fujirebio Inc. and the Real Time Stability study conducted at Fujirebio Diagnostics, Inc..
2.3 Open-vial (In-Use) Stability
In the on-going open-vial stability study (included in the real-time stability study), the Lumipulse G Prolactin calibrators are stored at 2-10 C and both calibrators were opened and then closed at the start of the study (Time Point). The Prolactin calibrators are tested in duplicate at specified intervals (6 months and 12 months) 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. The % CV value of each time point must be ≤ 10%.
The testing will continue with this stability protocol until data to support a claim of 12 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.
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable.
Clinical cut-off: 4. Not applicable.
- Expected values/Reference range: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, specificity and reproducibility were calculated in the long-term stability study. In the transport simulation study, sensitivity and accuracy were evaluated.
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized caduceus-like symbol, with three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
January 12, 2017
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
Re: K163544
Trade/Device Name: Lumipulse® G Prolactin 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 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.
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)
Device Name Lumipulse® G Prolactin
Indications for Use (Describe) Lumipulse G Prolactin Calibrators
Lumipulse & Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse & Prolactin 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 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 letters. Below the company name is the text "Diagnostics, Inc." in smaller, black letters.
Section 5 510(k) SUMMARY
Lumipulse® G Prolactin
January 6, 2017 Date:
- 510(k) Number: K163544
- 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
- Lumipulse® G Prolactin Calibrators Device Name: Classification: Class II JIT 75, Clinical Chemistry 21 CFR § 862.1150
- Predicate Device: K052982 ROCHE DIAGNOSTICS Cobas Elecsys Prolactin 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 Prolactin Calibrator kit contains 2 bottles (1,5 mL each) of Lumipulse G Prolactin Calibrators 1 and 2. Calibrator 2 contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Lumipulse® G Prolactin Calibrators CAL 230954, Liquid 1x2 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately.
- CAL 1 0 ng/mL Prolactin calibrator (1 x 1.5 mL)
CAL 2 400 ng/mL Prolactin calibrator (1 x 1.5 mL)
- Contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
4
Image /page/4/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 forming a partial circle with a white teardrop shape in the center. 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, thinner font, also in blue.
Device Name:
Lumipulse G Prolactin Calibrators
Device Intended Use:
Lumipulse G Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Prolactin on the LUMIPULSE G System.
Device Indications for Use:
Same as Intended Use
Substantial Equivalence:
Comparison between the Lumipulse G Prolactin Calibrators and Roche Diagnostics Cobas Elecsys Prolactin II Calset - C-
| Calibrator Set | ||
|---|---|---|
| Similarities and Differences | ||
| Parameter | Lumipulse G | |
| Prolactin | ||
| (Proposed Device) | Cobas Elecsys Prolactin II Calset | |
| (Predicate Device) | ||
| K052982 | ||
| Intended Use | Lumipulse G Prolactin Calibrators are | |
| for in vitro diagnostic use in the | ||
| calibration of Lumipulse G Prolactin on | ||
| the LUMIPULSE G System. | Elecsys Prolactin II CalSet is used | |
| for calibrating the quantitative | ||
| Elecsys Prolactin II assay on the | ||
| Elecsys immunoassay systems. | ||
| Instrument System | LUMIPULSE G System | Elecsys and cobas e |
| immunoassay analyzers | ||
| Analyte | Prolactin | Same |
| Number of Calibrators | 2 calibrators | Same |
| Standardization/Traceability | The calibrators for use with Lumipulse | |
| G Prolactin are prepared gravimetrically | ||
| and are traceable to the 3rd International | ||
| Standard, 1988 (code: 84/500) provided | ||
| by the National Institute for Biological | ||
| Standards and Control (NIBSC). | The assay is standardized using | |
| the 3rd IRP WHO Reference | ||
| Standard 84/500 | ||
| Level | 2 levels0 ng/mL and 400 ng/mL | 2 levelsLow: approx. 2 µIU/mLHigh: approx. 2,000 µIU/mL |
| Form | Liquid - ready to use | Same |
| Matrix | Sodium chloride in Tris buffer with | |
| protein stabilizer (bovine). Preservative: | ||
| sodium azide | Buffered equine serum |
5
Image /page/5/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 white shapes. To the right of the graphic is the text "FUJIREBIO" in a bold, blue sans-serif font. Below "FUJIREBIO" is the text "Diagnostics, Inc." in a smaller, black sans-serif 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.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability
The calibrators for use with Lumipulse G Prolactin are prepared gravimetrically and are traceable to the 3th International Standard, 1988 (code: 84/500) provided by the National Institute for Biological Standards and Control (NIBSC).
Value Assignment
Prolactin Antigen Grade is obtained from CLINIQA. The working stock solution is prepared by dissolving Prolactin antigen in 2-amino-2-hydroxymethyl-1,3propandiol-based buffer. The working stock solution is assigned a provision value based on the measurement using LUMIPULSE G Prolactin on the LUMIPULSE G System with secondary calibrators. Lumipulse G Prolactin Calibrators are made by calculating the amount of working stock solution and 2-amino-2-hydroxymethyl-1,3propandiol-based buffer required to achieve the desired 400 ng/mL calibrator value (Lumipulse G Prolactin Calibrator 2) and adding them together gravimetrically. The 0 ng/mL Calibrator (Lumipulse G Prolactin Calibrator 1) only contains the 2-amino-2hydroxymethyl-1,3-propandiol-based buffer. Lumipulse G Prolactin Calibrator 2 is rate-matched to the respective secondary calibrator based on the measurement in Lumipulse G Prolactin and adjusted if necessary. The measurement of Lumipulse G Prolactin Calibrators (10 replicates) and secondary calibrators (10 replicates) are performed on 3 runs using the LUMIPULSE G System. The mean ratio is the mean counts of the secondary calibrator to the respective Lumipulse G Prolactin Calibrator. The acceptable rate mean ratio is 0.95 - 1.05. This solution is stored at 2 to 10 °C.
| Calibrator | Target Values (ng/mL) | Target Range (ng/mL) |
|---|---|---|
| Cal 1 | 0 ng/mL | N/A |
| Cal 2 | 400 ng/mL | 380 – 420 ng/mL |
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 accelerated stability study the sponsor determined that the calibrators have a shelf-life stability of 12 months
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 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.
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 Prolactin Immunoreaction Cartridges and Calibrators as the LUMIPULSE G1200 System)
1. Studies conducted at Fujirebio, Inc. (Tokyo, Japan)
- 1.1 Long-term stability
The long-term stability data were obtained on the LUMIPULSE G System by measuring the Prolactin calibrators and samples for 3 lots of reagents that were stored at 10°C for 0, 3, 7, and 13 months. Sensitivity, specificity and reproducibility were calculated.
The results of sensitivity, accuracy and reproducibility confirmed that in a 13-month test. standards were met and the product passed. Therefore, the shelf life of the Lumipulse G Prolactin Calibrators stored at 2-10°C for 12 months was confirmed.
1.2 Transport Simulation
Transportation Testing (Temperature Stress Testing) data were obtained by stressing reagents. calibrator (standard solution), substrate solution, and diluent under the following conditions: 37°C, 48 hours ± 2 hours → -20°C, 48 hours ± 2 hours → 30°C, 96 hours ± 4 hours-> storage conditions (4°C), 24 hours ± 2 hours. Sensitivity, accuracy, and visual inspection were performed.
Visual assessment of 5 items was 0/28 under control conditions and 0/28 under stress conditions, thus meeting the specification. Sensitivity was 162 under control conditions and 171 under stress conditions, in each case meeting the S/N≥51 specification. Accuracy (versus test values) was 95-101% under control conditions and 99-109% under stress conditions, in each case meeting the specification for "within 100 ± 20%." Therefore, the results of sensitivity, accuracy, and visual inspection all met specification.
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 Prolactin calibrators are stored at 2-10 C. The Prolactin calibrators are tested 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).
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, followed by the company name in blue text. The graphic is a combination of blue and green shapes, resembling a stylized water droplet or leaf. The text "FUJIREBIO" is in a bold, sans-serif font, with "Diagnostics, Inc." in a smaller font size below it.
Time Point 2 (Month 6) was the second time point for testing. The Lumipulse G Prolactin 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.
2.2 Transport Simulation Stability Study
Transport simulation of the Lumipulse G Prolactin 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 ± 10 C 24±2 hours → 6 C ± 4 C 24±2 hours. To determine the impact of temperature on the Lumipulse G prolactin Calibrators, a performance analysis was conducted.
After each stress condition, all Lumipulse G Prolactin ICs and Lumipulse G Prolactin Calibrators were moved to the next cycle temperature. After all cycles were complete, a visual inspection was performed and the Lumipulse G Prolactin calibrators were stored at the intended storage condition of 2-10°C. Stressed Lumipulse G Prolactin 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. The stability study is ongoing.
Shelf life
The shelf life for Lumipulse G Prolactin Calibrators is 12 months at 2-10°C, based on the longterm stability study conducted at Fujirebio Inc. and the Real Time Stability study conducted at Fujirebio Diagnostics, Inc..
Transport Conditions
Lumipulse G Prolactin Calibrators are shipped at 2-10°C.
- 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 Prolactin calibrators are stored at 2-10 C and both calibrators were opened and then closed at the start of the study (Time Point). The Prolactin calibrators are tested in duplicate at specified intervals (6 months and 12 months) 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. The % CV value of each time point must be ≤ 10%.
8
Premarket Notification Lumipulse® G Prolactin
Image /page/8/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 that resemble a water droplet. To the right of the graphic is the company name, "FUJIREBIO," in bold, blue letters. Below the company name is the text "Diagnostics, Inc." in a smaller, black font.
The testing will continue with this stability protocol until data to support a claim of 12 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.
3. Clinical studies:
- 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: 4. Not applicable.
-
- Expected values/Reference range: 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, 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.
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.