For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.

Device Description

DC-UIBC-CAL is a human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC Assays. The concentrations and activities of the UIBC (Unsaturated Iron Binding Capacity) is optimized for the calibration of clinical chemistry systems - Beckman Coulter AU® Systems, Roche/Hitachi® Beckman Coulter SYNCHRON® Systems, and Cobas Mira®.

The DC-UIBC-CAL kit consists of the following:

Six vials with 10mL of lyophilized serum.

Human serum was used in the manufacture of this product. The human serum in this product has been prepared exclusively from the blood of donors tested individually and shown by FDAapproved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure, the directives of the responsible Health Authorities should be followed.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called DC-UIBC-CAL, a calibrator for clinical chemistry assays. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a full de novo performance study. As such, many of the typical elements requested for software-based AI/ML device studies are not present.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or not provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device.

The reported performance is primarily around stability and traceability/value assignment.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate	The information presented in the premarket notification demonstrates that the performance of the Sekisui Diagnostics modified DC-UIBC-CAL is substantially equivalent to the cleared predicate device.
Shelf Life Stability	Accelerated stability studies for shelf life were conducted, and acceptance criteria were met. The DC-UIBC-CAL is stable at 2-8 °C for 36 months or until the expiration date. Real-time studies are ongoing.
Open Vial Stability (Reconstituted)	Acceptance criteria were met. Reconstituted product is stable at 2-8 °C for 14 days.
Traceability of UIBC Values	UIBC values are traceable to NIST SRM 937. Sekisui verifies UIBC is within acceptable target range using Sekisui protocol.
Target Range Consistency Across Instruments	For UIBC-SL Reagent 153-10/30/50/90, the target range across Beckman Coulter AU, Beckman Coulter SYNCHRON, Roche/Hitachi, and Cobas Mira systems is 208 – 312 µg/dL. Specific target values are provided (e.g., 238 µg/dL for Beckman Coulter AU Systems).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document relates to a calibrator, not a diagnostic test for patient samples. Therefore, the concept of a "test set" for patient data, sample size, and data provenance (country, retrospective/prospective) as typically applied to diagnostic algorithms is not applicable here.

The stability studies would have involved multiple units of the calibrator product. The traceability and value assignment involved using two reagent lots on instruments. No specific sample sizes for these internal validation tests are provided.

The device itself is manufactured using human serum, and mentions that "Human serum was used in the manufacture of this product."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. The device is a calibrator, not an interpretative AI/ML diagnostic device. Ground truth for a calibrator relates to its chemical composition and assigned values, which are established through metrological traceability to reference materials (like NIST SRM 937) and internal protocols, not through expert human review of diagnostic outputs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for a calibrator device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML diagnostic device for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a calibrator, a physical reagent device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the calibrator's UIBC concentration is established through metrological traceability to a reference material, specifically NIST SRM 937 (National Institute of Standards and Technology Standard Reference Material 937). Internal Sekisui protocols are also used for value assignment. This is a chemical/physical ground truth, not a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

Not applicable. This is a calibrator, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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

SEKISUI DIAGNOSTICS P.E.I. INC. PENNY WHITE REGULATORY AFFAIRS MANAGER 70 WATTS AVENUE CHARLOTTETOWN C1E 2B9 CA

December 8, 2016

Re: K163078

Trade/Device Name: DC-UIBC-CAL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: October 31, 2016 Received: November 8, 2016

Dear Ms. White:

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 (OS) 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/ResourcesforYou/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) K163078

Device Name DC-UIBC-CAL

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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SEKISUI

510(k) Summary Safety and Effectiveness for the DC-UIBC-CAL

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

1. 510(k) Number: K163078

2. Applicant Name and Address

Contact Person:	Penny WhiteRegulatory Affairs Manager
Company Name:	Sekisui Diagnostics P.E.I. Inc
Address:	70 Watts AvenueCharlottetown, PE, C1E 2B9Canada
Telephone:	902-628-0934902-628-6504 (FAX)

3. Date: 2016-12-06

1. Proprietary and Established Names DC-UIBC-CAL

5. Regulatory Information:

Regulation section: 21 CFR 862.1150, Calibrator, Secondary Classification: Class II Product Code: JIT Panel: Clinical Chemistry

6. Purpose of the 510(k) submission

The DC-UIBC-CAL is being modified from a bovine and human serum matrix to strictly a human serum matrix.

7. Predicate Device

Device Name: DC-UIBC- Cal, SE-090 510(k) Number: K925877 Manufacturer: Sekisui Diagnostics PEI Inc.

8. Intended Use:

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9. Indications for Use:

The DC-UIBC-CAL, used in conjunction with UIBC reagents, is intended for use in automated analyzers for the calibration of UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.

10. Device Description

The DC-UIBC-CAL kit consists of the following:

Six vials with 10mL of lyophilized serum.

11. Test Principle

DC-UIBC-CAL is a human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC methodologies. The concentrations and activities of the analyte UIBC is optimized for the calibration of clinical chemistry systems.

12. Substantial Equivalence Information

Predicate device name: DC-DC-UIBC-CAL, SE-090 Predicate number: K925877 Comparison with Predicate:

Similarities
Characteristics	DC-UIBC-CALSE-090	Predicate DC-UIBC-CALSE-090
Features	DC-UIBC-CALSE-090Calibrator. Human BasedLyophilized serum	Same
Intended Use	For IN VITRO diagnostic useas a calibrator in clinicalchemistry assaysfor UIBC (Unsaturated IronBinding Capacity). DC-UIBC-CAL may beused to check the linearity overthe reportable patient range ofUIBC assays.	Same
Packaging CalibratorDiluent	6 x 10ml	Same
Format	Lyophilized	Same
Levels	1 Level	Same
Storage	2-8°C until expiration date	Same
Reconstituted Stability at 2-8°C	14 days	Same
Analytes	UIBC (Unsaturated IronBinding Capacity).	Same
Traceability	The assigned values for theconstituents are traceable toreference materials from NIST	Same

Sekisui Diagnostics P.E.I. Inc.

70 Watts Avenue Charlottetown, Prince Edward Island C1E 2B9 Canada Tel: 902-566-1396 Fax: 902-628-650

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SEKISUI

Characteristic	DC-UIBC-CALSE-090	Predicate DC-UIBC-CAL SE-090
Matrix	Calibrator is prepared fromhuman serum and diluted withdeionized water.	Calibrator is prepared frombovine and human serum anddiluted with deionized water.

13. Standard/Guidance Document Reference

The following recognized standard and guidance documents were used:

. Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
ISO 17511:2003 - In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
o CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline

14. Performance Characteristics

The following studies are not applicable for the purpose if this submission as outlined in Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators

Precision/Reproducibility ●
Linear/Assay Reportable Range ●
Detection Limit ●
Method and Matrix Comparison Studies ●
Analytical Specificity ●
Assay cut-off ●
Expected Values/Reference Intervals ●

Stabilitv

Accelerated stability studies for shelf life and open vial claims have been conducted and acceptance criteria were met. The DC-UIBC-CAL is to be stored at 2-8 ℃ for 36 months or until the expiration date printed on each carton. Real time stability studies for shelf life are on-going. The final shelf life claims will be based on the completed real time study results. Reconstituted product is stable at 2-8 °C for 14 days. The reconstituted calibrator should be brought to room temperature (18-26 ℃) before assaying.

Traceability and Value Assignment

Sekisui verifies that the Unsaturated Iron Binding Capacity is within the acceptable target range using the Sekisui protocol. DC-UIBC-CAL value assignments are completed using two reagent lots on instruments listed in the product insert. The Unsaturated Iron Binding Capacity in this calibrator is traceable using ISO 17511 to the reference material below:

Constituent	Material Reference
UIBC	NIST SRM 937

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SEKISUI

UIBC-SL Reagent153-10/30/50/90
Instrument	(µg/dL)	TargetRange(µg/dL)
Beckman Coulter AU Systems	238
Beckman CoulterSYNCHRON Systems	236	208 – 312
Roche/Hitachi	237
Cobas Mira	235

Refer to the below table for representative target concentration for the UIBC in DC-UIBC- CAL kit.

15. Conclusion

The information presented in the premarket notification demonstrates that the performance of the Sekisui Diagnostics modified DC-UIBC-CAL is substantially equivalent to the cleared predicate device.

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.