(385 days)
No
The document describes a change in the formulation and packaging of a calibrator for an in vitro diagnostic test. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical and physical properties of the calibrator.
No.
This device is a calibrator used for an in vitro diagnostic test (PATHFAST cTnI-II test) that measures cardiac Troponin I, which aids in the diagnosis of acute myocardial infarction. It does not directly treat or prevent a disease or condition.
No
The device is described as "PATHFAST® cTnl Calibrators" which are used for calibration of a system that performs quantitative determination of cardiac Troponin I. The document explicitly states, "The PATHFAST cTnl Calibrators are for calibration of the PATHFAST instrument." Calibrators are used to ensure the accuracy of a diagnostic device, they are not diagnostic devices themselves.
No
The device is a calibrator, which is a physical substance used to calibrate a medical instrument. The description details changes to the physical formulation and container of the calibrator, indicating it is a hardware component (a reagent/calibrator) and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are for "calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma." This involves testing human biological samples in vitro (outside the body).
- Device Description: The description further clarifies that the calibrators are used with the "PATHFAST cTnI-II test performed on the PATHFAST instrument," and that this test is an "in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma."
- Purpose: The overall purpose is to aid in the diagnosis of acute myocardial infarction by providing accurate measurements of cardiac Troponin I in patient samples. This is a classic application of an in vitro diagnostic device.
The fact that it's a calibrator for an IVD test doesn't change its classification as an IVD itself, as it's an essential component used in the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The PATHFAST® cTnI Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
Product codes
JIT
Device Description
The PATHFAST® cTnI Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
The PATHFAST cTnl Calibrators are for calibration of the PATHFAST cTnl-II test performed on the PATHFAST instrument. PATHFAST cTnI-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Currently, PATHAST cTnl Calibrators 1 and 2 are provided as lyophilized products of two vials each. Calibrator 1 consists of buffer only and Calibrator 2 consists of cTnI complex 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 cTnl Calibrator 2. As a result of elimination of the reconstitution step for PATHFAST cTnI Calibrator 1, the number of bottles of Calibrator Diluent is being reduced from four bottles to two bottles.
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
As part of the company's Design Control system, the following validation/verifications studies were performed.
- Formulation: assay sensitivity, accuracy, and precision, method comparison, sample type and matrix comparison
- Format: real time stability
- Container: elution and evaporation
The results of the validation and verification testing demonstrate that the modified PATHFAST cTnl Calibrator 1 met all specifications for the studies identified in the company's design control system Risk Analysis.
Key Metrics
Not Found
Predicate Device(s)
PATHFAST cTnI Calibrator 1 which is supplied with the PATHFAST cTnI-II Test [K100130, 5/16/2011]
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510 (k) – PATHFAST® cTnI Calibrator 1
510(k) SUMMARY
February 28, 2014
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: K130603
| CONTACT: | Judi Smith
Precision for Medicine
2 Bethesda Metro Center, Suite 850
Bethesda, MD 20814
on behalf of:
Mitsubishi Chemical Medience Corporation
2-8, Shibaura 4-chome, Minato-ku
Tokyo, 108-8559 Japan |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE:
Trade Name: | PATHFAST cTnI Calibrator 1 |
| Common/Classification Names: | Calibrator |
| Regulation Number: | 862.1250 |
| Product Code: | JIT |
| Class: | II |
| PREDICATE DEVICE: | PATHFAST cTnI Calibrator 1 which is
supplied with the PATHFAST cTnI-II Test
[K100130, 5/16/2011] |
DEVICE DESCRIPTION:
INTENDED USE:
The PATHFAST® cTnI Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
PRODUCT DESCRIPTION:
The PATHFAST cTnl Calibrators are for calibration of the PATHFAST cTnl-II test performed on the PATHFAST instrument. PATHFAST cTnI-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of
1
Special 510 (k) - PATHFAST® cTnI Calibrator 1 510(k) SUMMARY (cont.)
cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction.
Currently, PATHAST cTnl Calibrators 1 and 2 are provided as lyophilized products of two vials each. Calibrator 1 consists of buffer only and Calibrator 2 consists of cTnI complex 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 cTnl Calibrator 2. As a result of elimination of the reconstitution step for PATHFAST cTnI Calibrator 1, the number of bottles of Calibrator Diluent is being reduced from four bottles to two bottles.
SUBSTANTIAL EQUIVALENCE:
The PATHFAST cTnl Calibrator 1 (liquid format) is substantially equivalent to the PATHFAST cTnl Calibrator 1 (lyophilized format) (K100130) in intended use and design. The similarities and differences are listed below.
| SIMILARITIES | ||
|---|---|---|
| Item | PATHFAST cTnI Calibrator 1 | |
| Lyophilized | ||
| (predicate device) | PATHFAST cTnI Calibrator 1 | |
| Liquid | ||
| (Modified) | ||
| FDA Submission | ||
| Number | K100130 | N/A |
| Intended Use | The PATHFAST® cTnI | |
| Calibrators are for calibration of | ||
| the PATHFAST® system when | ||
| used for the quantitative | ||
| determination of cardiac Troponin | ||
| I in human heparinized or EDTA | ||
| whole blood and plasma. | No change | |
| Fundamental | ||
| Scientific | ||
| Technology | cTnI concentration = 0 ng/mL. | |
| Provides zero analyte level for | ||
| user calibration curve. | No change | |
| Value | ||
| Assignment | Primary calibrator, master | |
| calibrator, stock solution, | ||
| working calibrator | No change | |
| Instructions | Dispense approximately 100 µL | |
| of CAL-1 and CAL-2 in sample | ||
| wells to load on PATHFAST. | No change |
Substantial Equivalence Comparison Table
2
Special 510 (k) - PATHFAST® cTnI Calibrator 1 510(k) SUMMARY (cont.)
| DIFFERENCES | ||
|---|---|---|
| Item | PATHFAST cTnI Calibrator 1 | |
| Lyophilized | ||
| (predicate device) | PATHFAST cTnI Calibrator 1 | |
| Liquid | ||
| (Modified) | ||
| Formulation | Lyophilized MES pH 6.0, | |
| lactose, and enzyme free human | ||
| serum, DTT | Liquid saline solution with 0.05% | |
| sodium azide as preservative | ||
| Format | Lyophilized | Liquid |
| Calibrator 1 | ||
| Container | Silicon-coated glass bottle with | |
| silicone rubber and plastic screw | ||
| cap | Polypropylene droplet bottle with | |
| high density polyethylene nozzle | ||
| and polypropylene screw cap | ||
| Calibrator | ||
| Quantity | CAL-1 (1mL lyophilized× | |
| 2vials) | ||
| CAL-2 (1mL lyophilized×2vials) | ||
| Calibrator Diluent (1mL×4 | ||
| bottles) | CAL-1 (2mL liquid×1 bottle) | |
| CAL-2 (1mL lyophilized ×2vials) | ||
| (no change) | ||
| Calibrator Diluent (1mL×2 | ||
| bottles) | ||
| Instructions | Reconstitute each vial of CAL-1 | |
| and CAL-2 with one bottle | ||
| (1mL) of Calibrator Diluent. | Reconstitute CAL-2 with one | |
| bottle (1mL) of Calibrator | ||
| Diluent. |
As part of the company's Design Control system, the following validation/verifications studies were performed.
- Formulation: assay sensitivity, accuracy, and precision, method comparison, . sample type and matrix comparison
- Format: real time stability .
- Container: elution and evaporation .
The results of the validation and verification testing demonstrate that the modified PATHFAST cTnl Calibrator 1 met all specifications for the studies identified in the company's design control system Risk Analysis. Therefore, the modified PATHFAST cTnl Calibrator 1 is substantially equivalent to the current 510(k)-cleared PATHFAST cTnI Calibrator 1.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Aveme Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
March 27, 2014
MITSUBISHI CHEMICAL MEDIENCE CORPORATION C/O JUDI SMITH 2 BETHESDA METRO CENTER SUITE 850 BETHESDA MD 20814
Rc: K130603
Trade/Device Name: PATHFAST cTnl Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: March 18. 2014 Received: March 19. 2014
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 reclassilied 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. Ilsting 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 1000-1050.
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 (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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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 vours.
Courtney H. Lias -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K130603
Device Name
PATHFAST® cTnI Calibrators
Indications for Use (Describe)
The PATHFAST® cTnl Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
Type of Use (Select one or both, as applicable)
12 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
A. Chesler -S
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