(57 days)
Not Found
No
The document describes a calibrator for an in vitro diagnostic device, which is a chemical reagent product, not a software or imaging device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an in vitro diagnostic product intended for calibrating a cardiac troponin I method on an analyzer. It establishes a point of reference for determining troponin I values, which is for diagnostic purposes, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Cardiac Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration..."
No
The device description clearly states it is a "plastic cartridge" containing "buffered bovine protein," indicating it is a physical, hardware-based product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the "Intended Use / Indications for Use": The very first sentence clearly states, "The Cardiac Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product..."
- Function aligns with IVD definition: The device is intended to be used in vitro (outside the body) to calibrate a method for determining a substance (cardiac troponin I) in a sample (presumably blood or serum, although not explicitly stated, this is the typical sample for troponin testing). This is a core function of an IVD.
- Used for calibration of a diagnostic test: The calibrator is used to ensure the accuracy of the Stratus® CS analyzer when measuring cardiac troponin I, which is a diagnostic marker.
Therefore, based on the provided information, the Cardiac Troponin I Calibrator (cTnI CalPak) is definitively an IVD.
N/A
Intended Use / Indications for Use
The Cardiac Troponin I Calibrator (cTnI CalPak) is intended to be used for calibration of the cardiac troponin I method on the Stratus® CS analyzer.
The Cardiac Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the cardiac troponin I method product meetided to valyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Stratus® CS cTnI CalPak is a plastic cartridge, which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concertration to troponin complex per well is 40 ng/mL. The CalPak is a single-use product.
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
§ 862.1150 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
Dade Behring
K012233 Summary of Safety and Effectiveness Information
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitter's Name | Elaine H. Kindell
Dade Behring Inc.
P. O. Box 6101, Mailbox 514
Newark, DE 19714-6101 |
|--------------------------|------------------------------------------------------------------------------------------------|
| Date of Preparation: | July 12, 2001 |
| Device Name: | Stratus® CS Troponin I Calibrator (cTnI Cal Pak) |
| FDA Classification Name: | Calibrator, secondary |
| Predicate Device: | Stratus® CS TROP CalPak (K983722) |
Device Description: The Stratus® CS cTnI CalPak is a plastic cartridge, which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concertration to troponin complex per well is 40 ng/mL. The CalPak is a single-use product.
Intended Use: The Cardiac Troponin I Calibrator (cTnI CalPak) is intended to be used for calibration of the cardiac troponin I method on the Stratus® CS analyzer.
Comparison to Predicate Device:
| Item | Stratus ® CS cTnI Cal Pak (modified) | Stratus ® CS TROP Cal Pak (K983722) |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | Native human troponin complex | Native human troponin complex |
| Matrix | Normal human serum | Buffered bovine protein |
| Form | Frozen | Frozen |
| Target | ||
| Concentration | 40 ng/mL | 40 ng/mL |
| Values | Assigned | Assigned |
| Packaging | ||
| Configuration | ||
| Values | Single use plastic cartridge | Single use plastic cartridge |
| Levels | One | One |
1
Comments On Substantial Equivalence: The Stratus® CS cTnI CalPak (modified) is equivalent to the Stratus® CS TROP CalPak (K983722) currently marketed. The modified Stratus® CS cTnI CalPak has uses with a normal human serum base versus the buffered bovine protein matrix and associated stabilizers used in the currently marketed product. Both products are intended to be used as calibrators for the Stratus® CS Cardiac Troponin I method.
Conclusion: The modified Stratus® CS cTnI CalPak is substantially equivalent to the Stratus® CS TROP CalPak currently marketed by Dade Behring based on the comparison summarized above.
Elaine H Kindell
Elaine H. Kindell Quality Assurance and Compliance Manager Date: July 12, 2001
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a wavy, flowing design. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Ms. Elaine H. Kindell Quality Assurance and Compliance Manager Dade Behring Inc. Glasglow Business Community P.O. Box 6101, Building 500 Newark, DE 19714
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2001
K012233 Re:
Trade/Device Name: Stratus ® CS Troponin I Calibrator (cTnI CalPak) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 12, 2001 Received: July 16, 2001
Dear Ms. Kindell:
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 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 Part 801); 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.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Statement
Device Name:
Stratus® CS Troponin I Calibrator (cTnI CalPak)
Indications for Use: The Cardiac Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the cardiac troponin I method product meetided to valyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.
Elaine H. Kendall
Elaine H. Kindell Quality Assurance and Compliance Manager
July 12, 2001
Date
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander Jordan Cooper
(Division Sign-C
Division of Clin vices
510(k) Number
Division Sign-Off
Prescription Use (Per 21 CFR 801.109)
OR
K012233
510(k) Number
Office of Device Evaluation
Over-the-counter Use __
(Optional format 1-2-96)