PATHFAST CK-MB-II CALIBRATORS

K130628 · Mitsubishi Chemical Medience Corporation · JIT · Oct 4, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130628
• Device Name: PATHFAST CK-MB-II CALIBRATORS
• Applicant: Mitsubishi Chemical Medience Corporation
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 4, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The PATHFAST® CK-MB-II Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of creatine kinase-MB in human heparinized or EDTA whole blood and plasma.

Device Story

PATHFAST CK-MB-II Calibrators are liquid-based reference materials used to calibrate the PATHFAST system for quantitative measurement of creatine kinase-MB (CK-MB) in human heparinized or EDTA whole blood and plasma. The device consists of a liquid Calibrator 1 (saline and preservative) and a lyophilized Calibrator 2 (CK-MB in buffer). The system is used in clinical settings to ensure accurate analyte quantification. The calibrators are loaded into the PATHFAST instrument to establish a calibration curve. By providing a known zero-analyte level (Calibrator 1) and a CK-MB concentration (Calibrator 2), the device enables the instrument to accurately measure patient samples, aiding clinicians in diagnosing or monitoring cardiac conditions associated with CK-MB levels.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to assess impact of formulation and packaging changes. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Liquid calibrator formulation; dropper bottle container; used with PATHFAST Immunoanalyzer; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for use as a calibrator for the PATHFAST CK-MB-II assay on the PATHFAST Immunoanalyzer to ensure accurate quantitative measurement of CK-MB in human whole blood or plasma samples.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• PATHFAST CK-MB-II Calibrator 1 (K081360)

Submission Summary (Full Text)

{0}------------------------------------------------

#### Special 510 (k) - PATHFAST® CK-MB-II Calibrator 1

#### 510(k) SUMMARY

#### September 4, 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: __k130628

CONTACT:

Judi Smith Precision for Medicine 2 Bethesda Metro Center, Suite 850 Bethesda, MD 20814

PATHFAST CK-MB-II Calibrator 1

on behalf of: Mitsubishi Chemical Medience Corporation 2-8, Shibaura 4-chome, Minato-ku Tokyo, 108-8559 Japan

NAME OF DEVICE: Trade Name:

Common/Classification Names:

Regulation Number:

Product Code:

Class:

PREDICATE DEVICE:

PATHFAST CK-MB-II Calibrator 1 which is supplied with the PATHFAST CK-MB-II Test [k081360, 8/17/2008]

OCT 0 4 2013

#### DEVICE DESCRIPTION:

INTENDED USE:

The PATHFAST® CK-MB-II Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of creatine kinase-MB in human heparinized or EDTA whole blood and plasma.

Calibrator

862.1150

JIT

I I

#### PRODUCT DESCRIPTION:

The PATHFAST CK-MB-II Calibrators are used for calibration of the PATHFAST CK-MB-11 test performed on the PATHFAST instrument. PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative

#### 510(k) Summary-l

{1}------------------------------------------------

#### Special 510 (k) - PATHFAST® CK-MB-II Calibrator 1

measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma.

Currently, PATHAST CK-MB-II Calibrators 1 and 2 are provided as lyophilized products of two vials each. Calibrator 1 consists of saline and a preservative, and Calibrator 2 consists of CK-MB in buffer. Four vials of calibrator diluent also are provided for reconstitution of the calibrators. The diluent consists of an aqueous solution with 0.05% sodium azide. This Special 510(k) is being submitted for a change to a liquid Calibrator 1 formulation and a new dropper bottle container. There are no changes to PATHFAST CK-MB-11 Calibrator 2. As a result of elimination of the reconstitution step for PATHFAST CK-MB-II Calibrator I, the number of bottles of Calibrator Diluent is being reduced from four bottles to two bottles.

#### SUBSTANTIAL EQUIVALENCE:

The PATHFAST CK-MB-II Calibrator 1 (liquid format) is substantially equivalent to the PATHFAST CK-MB-II Calibrator 1 (lyophilized format) (K081360) in intended use and design. The similarities and differences are listed below.

| SIMILARITIES | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Item | PATHFAST CK-MB-II<br>Calibrator 1<br>Lyophilized<br>(predicate device) | PATHFAST CK-MB-II<br>Calibrator 1<br>Liquid<br>(Modified) |
| FDA Submission<br>Number | k081360 | k130628 |
| Intended Use | The PATHFAST® CK-MB-11<br>Calibrators are for calibration of<br>the PATHFAST® system when<br>used for the quantitative<br>determination of creatine kinase-<br>MB in human heparinized or<br>EDTA whole blood and plasma. | No change |
| Fundamental<br>Scientific<br>Technology | CK-MB concentration = $0$<br>ng/mL. Provides zero analyte<br>level for user calibration curve. | No change |
| Value<br>Assignment | Primary calibrator, master<br>calibrator, stock solution,<br>working calibrator | No change |
| Instructions | Dispense approximately 100 µL<br>of CAL-1 and CAL-2 in sample | No change |

#### Substantial Equivalence Comparison Table

510(k) Summary-2

{2}------------------------------------------------

### Special 510 (k) – PATHFAST® CK-MB-II Calibrator 1

| | wells to load on PATHFAST. | |
|---------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| DIFFERENCES | | |
| Item | PATHFAST CK-MB-II<br>Calibrator 1<br>Lyophilized<br>(predicate device) | PATHFAST CK-MB-II<br>Calibrator 1<br>Liquid<br>(Modified) |
| Formulation | Lyophilized MOPS pH7.2.<br>lactose, and enzyme free human<br>serum, DTT | Liquid saline solution with 0.05%<br>sodium azide as preservative |
| Format | Lyophilized | Liquid |
| Calibrator 1<br>Container | Silicon-coated glass bottle with<br>silicon rubber and plastic screw<br>cap | Polypropylene droplet bottle with<br>high density polyethylene nozzle<br>and polypropylene screw cap |
| Calibrator<br>Quantity | CAL-1 (1mL lyophilized×<br>2vials)<br>CAL-2 (1mL lyophilized×2vials)<br>Calibrator Diluent (1mL×4<br>bottles) | CAL-1 (2mL liquid×1bottle)<br>CAL-2 (1mL-lyophilized ×2vials)<br>(no change)<br>Calibrator Diluent (1mL×2<br>bottles) |
| Instructions | Reconstitute each vial of CAL-1<br>and CAL-2 with one bottle<br>(1mL) of Calibrator Diluent | Reconstitute CAL-2 with one<br>bottle (1mL) of Calibrator<br>Diluent |

As part of the company's Design Control svstem, the following validation/verifications studies were performed.

- Formulation: assay sensitivity, Limit of Blank, Limit of Detection, Limit of . Quantitation, accuracy, method comparison, matrix comparison, and precision
- . Format: real time stability
- Container: elution and evaporation

The results of the validation and verification testing demonstrate that the modified PATHFAST CK-MB-II Calibrator 1 met all pre-established acceptance criteria for the studies identified in the company's design control system Risk Analysis. Therefore, the modified PATHFAST CK-MB-II Calibrator I`is substantially equivalent to the current 510(k)-cleared PATHFAST CK-MB-II Calibrator 1. .

510(k) Summarv-3

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in uppercase letters and is positioned to encircle the symbol.

Public Health Service .

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

October 4, 2013

Mitsubishi Chemical Medience Corporation c/o Ms. Judi Smith 2 Bethesda Metro Center, Suite 850 Bethesda, MD 20814

Re: K130628

Trade/Device Name: PATHFAST CK-MB-II CALIBRATORS Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: September 04, 2013 Received: September 05, 2013

Dear Ms. Smith:

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 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-ા 050.

{4}------------------------------------------------

Page 2-Ms. Smith

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm Also, plaase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFFP Past 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.him 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 Small Manufacturers, International and Consumer Assistance at its toll free no [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias, Ph.D.

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

{5}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): K130628

Device Name: PATHFAST® CK-MB-II Calibrators

Indication For Use:

The PATHFAST® CK-MB-11 Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of creatine kinase-MB in human heparinized or EDTA whole blood and plasma.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiological Health (OIR)

# Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Devices and Radiological Health

k130628 210(k)

Page I of I