(198 days)
Not Found
No
The summary describes a standard ELISA assay for measuring a biomarker (ST2) and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic device used to measure ST2 in patient samples as an aid in assessing prognosis, not directly for therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device..." and further describes its use "as an aid in assessing the prognosis of patients diagnosed with chronic heart failure." This clearly indicates its role in diagnosis or prognostic assessment.
No
The device description explicitly states it is an "in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format," which involves physical reagents and laboratory procedures, not solely software.
Yes, the provided text explicitly states that the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section begins with: "The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device..."
The "Device Description" section also states: "The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device..."
N/A
Intended Use / Indications for Use
The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
The Presage® ST2 Assay Kit Controls, Level 1 and Level 2, are designed to be used for monitoring the performance of test procedures on the Critical Diagnostics Presage® ST2 Assay kit.
Product codes (comma separated list FDA assigned to the subject device)
OYG, JJX
Device Description
Not Found
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)
Not Found
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.
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
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
0
510(k) Summary
ે.
| Submitter's name:
Address: | Critical Diagnostics
3030 Bunker Hill St., Ste 115A
San Diego, CA 92109 | DEC - 9 2011 |
|--------------------------------|-------------------------------------------------------------------------------|--------------|
| Phone: | (858) 270-2400 . | |
| Fax number: | (866) 715-8009 | |
| Email: | jsnider@criticaldiagnostics.com | |
| Name of contact person: | James V. Snider | |
| Date the summary was prepared: | December 7, 2011 | |
| Name of the device: | Presage® ST2 Assay | |
| Trade or proprietary name: | Presage® ST2 Assay | |
| Common or usual name: | ST2 Assay | |
| Classification name: | B-type natriuretic peptide test system | |
| Classification | 2 | |
| Product Code | OYG, ST2 Assay, JJX, Quality Control Material | |
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K093758 | Galectin-3 Assay | BG-Medicine |
Indication for Use:
The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
The Presage® ST2 Assay Kit Controls, Level 1 and Level 2, are designed to be used for monitoring the performance of test procedures on the Critical Diagnostics Presage® ST2 Assay kit.
Substantial Equivalence
The device and test method contained within the premarket notification and described in the labeling is within a generic type of device described under 21 CFR section 862.1117 and is substantially equivalent to other devices legally marketed in the United States such as the BG Medicine Galectin-3 Assay (K093758).
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Critical Care Diagnostics, Inc c/o James Snider, Ph.D. 3030 Bunker Hill St., Ste 115A San Diego, CA 92109
DEC - 9 2011
Re: K111452
Trade Name: Presage® ST2 Assay Kit, Presage ST2 Assay Kit Controls Regulation Number: 21 CFR §862.1117 Regulation Name: B-type Natriuretic Peptide test system. · Regulatory Class: Class II Product Codes: OYG, JJX Dated: December 5, 2011 Received: December 6, 2011
Dear Dr. Snider:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I DA 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's " Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours.
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use Form
510(k) Number (if known): K111452
Device Name: Presage® ST2 Assay by Critical Diagnostics
Indications for Use:
The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
The Presage® ST2 Assay Kit Controls, Level 1 and Level 2, are designed to be used for monitoring the performance of test procedures on the Critical Diagnostics Presage® ST2 Assay kit.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruth Cherlin
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 452