K Number

Device Name

DC-UIBC-CAL

Manufacturer

SEKISUI DIAGNOSTICS P.E.I. INC.

Date Cleared

2016-12-08

(35 days)

Product Code

JIT

Regulation Number

862.1150

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K925877

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a calibrator for in vitro diagnostic assays and the description focuses on its composition, intended use, and stability, with no mention of AI or ML.

Therapeutic

No.
This device is an in vitro diagnostic calibrator used in clinical chemistry assays, not a device intended for treating or diagnosing diseases in a patient.

Diagnostic

This device is described as a calibrator for in vitro diagnostic assays, not a diagnostic device itself. It is used to check the linearity of UIBC assays and optimize the calibration of clinical chemistry systems.

SaMD (Software as a Medical Device)

The device is a physical, lyophilized serum product intended for in vitro diagnostic use as a calibrator. It is not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states "For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity)." This is the primary indicator of an IVD.
Device Description: It describes the product as a "human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC Assays." Calibrators are essential components used in IVD tests to ensure accurate measurements.
Intended User/Care Setting: It reiterates "For IN VITRO diagnostic use."
Summary of Performance Studies: While it states certain studies are not applicable for this type of submission, the context is within the framework of IVD device regulation (Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators).
Predicate Device(s): The predicate device listed (K925877; DC-UIBC- Cal, SE-090) is also an IVD calibrator, further confirming the device's classification.

The entire description and context clearly indicate that this device is designed to be used in vitro (outside the body) to calibrate diagnostic tests performed on biological samples (serum) to measure a specific analyte (UIBC) for clinical purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JIT

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ●

Stability:
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: UIBC, Material Reference: NIST SRM 937

Representative target concentrations for UIBC in DC-UIBC-CAL kit:
Instrument: Beckman Coulter AU Systems, (µg/dL): 238, Target Range (µg/dL): Not Specified
Instrument: Beckman Coulter SYNCHRON Systems, (µg/dL): 236, Target Range (µg/dL): 208 – 312
Instrument: Roche/Hitachi, (µg/dL): 237, Target Range (µg/dL): Not Specified
Instrument: Cobas Mira, (µg/dL): 235, Target Range (µg/dL): Not Specified

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K925877

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

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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked, overlapping manner. The profiles are rendered in a dark color, creating a sense of depth and unity. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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.

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

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 White
Regulatory Affairs Manager |
|-----------------|---------------------------------------------------------|
| Company Name: | Sekisui Diagnostics P.E.I. Inc |
| Address: | 70 Watts Avenue
Charlottetown, PE, C1E 2B9
Canada |
| Telephone: | 902-628-0934
902-628-6504 (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:

9. Indications for Use:

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-CAL
SE-090
Features	DC-UIBC-CALSE-090
Calibrator. Human Based
Lyophilized serum	Same
Intended Use	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.	Same
Packaging Calibrator
Diluent	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 Iron
Binding Capacity).	Same
Traceability	The assigned values for the
constituents are traceable to
reference 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

SEKISUI

| Characteristic | DC-UIBC-CALSE-090 | Predicate DC-UIBC-
CAL SE-090 |
|----------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Matrix | Calibrator is prepared from
human serum and diluted with
deionized water. | Calibrator is prepared from
bovine and human serum and
diluted 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

SEKISUI

| UIBC-SL Reagent

153-10/30/50/90
Instrument	(µg/dL)	Target
Range
(µg/dL)
Beckman Coulter AU Systems	238
Beckman Coulter
SYNCHRON 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.