(14 days)
Not Found
No
The document describes a calibrator for a laboratory analyzer, which is a chemical reagent product, not a software or imaging device typically associated with AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a calibrator used to calibrate an analyzer, not to treat a condition or disease.
No
The device is a calibrator for a diagnostic method, not a diagnostic device itself. Its purpose is to calibrate an analyzer, ensuring the accuracy of the diagnostic test.
No
The device description explicitly states it is a "plastic cartridge" containing physical substances, indicating it is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's used to "calibrate the Cardiac Troponin I method on the Stratus® CS analyzer." Calibration is a crucial step in ensuring the accuracy of an in vitro diagnostic test.
- Device Description: The description mentions it contains "buffered bovine protein with native human troponin complex." This indicates it's a biological material used in a laboratory setting to interact with a sample (presumably blood or serum) to measure a specific analyte (Cardiac Troponin I).
- Context: The device is designed to be used with the Stratus® CS analyzer, which is a system used for performing in vitro diagnostic tests.
- Predicate Device: The predicate device listed is also named "Stratus® CS TROP CalPak," further reinforcing its role as a component within an IVD system.
While the document doesn't explicitly state "in vitro diagnostic," the combination of its intended use for calibrating a diagnostic method and its composition as a biological material used in a laboratory setting clearly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TROP CalPak is intended to be used for calibration of the Cardiac Troponin I method on the Stratus® CS analyzer.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Stratus® CS TROP CalPak is a plastic cartridge which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concentration of 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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '4', '8', '3', '7', and '2'. The digits are written in a connected manner, resembling cursive handwriting. The image appears to be a close-up of the handwritten sequence.
Image /page/0/Picture/1 description: The image shows the text "NOV 4 1998". The text is in a bold, sans-serif font. The letters and numbers are all black. The background is white.
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Dade Behring
Summary of Safety and Effectiveness Information
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.
| Submitter's Name: | Rebecca S. Ayash
Dade Behring Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101
Phone: (302) 631-6276
FAX: (302) 631-6299 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 10/21/98 |
| Device Name: | Stratus® CS Troponin I Calibrator (TROP CalPak) |
| Classification Name: | Calibrator, secondary |
| Predicate Device: | Stratus® CS TROP CalPak (K981100) |
Device Description: The Stratus® CS TROP CalPak is a plastic cartridge which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concentration of troponin complex per well is 40 ng/mL. The CalPak is a single-use product.
Intended Use: The TROP CalPak is intended to be used for calibration of the Cardiac Troponin I method on the Stratus® CS analyzer.
Comparison to Predicate Device:
| | Stratus® CS TROP CalPak
(Modified) | Stratus® CS TROP CalPak
(K981100) |
|-------------------------|---------------------------------------|--------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | Native human troponin complex | Troponin-I peptide fragment |
| Matrix | Buffered bovine protein | Buffered bovine protein |
| Form | Frozen | Frozen |
| Target Concentration | 40 ng/mL | 45 ng/mL |
| Values | Assigned | Assigned |
| Packaging Configuration | Single use plastic cartridge | Single use plastic cartridge |
| Levels | One | One |
1
Comments on Substantial Equivalence: The Stratus® CS TROP CalPak (modified) is equivalent to the Stratus® CS TROP CalPak currently marketed. Both products are manufactured using a buffered bovine protein matrix but differ in analyte source. Both products are intended to be used as calibrators for the Stratus® CS Cardiac Troponin I method.
Conclusion: The modified Stratus® CS TROP CalPak is substantially equivalent to the Stratus® CS TROP CalPak currently marketed by Dade Behring based on the companson summarized above.
Rebecca S. Ayash
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 10/21/98
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
NOV 4 1998
Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager DADE BEHRING, INC. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re : K983722 Trade Name: Stratus® CS Troponin-I Calibrator (TROP CalPak) Requlatory Class: II Product Code: JIT Dated: October 21, 1998 Received: October 21, 1998
Dear Ms. Ayash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3
Page 2
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 requlation (21 CFR Part 801 and 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
.İ.
4
Indications Statement
Device Name: Stratus® CS Troponin I Calibrator (TROP CalPak)
Indications for Use: The Cardiac Troponin-I Calibrator (TROP CalPak) is intended to be used to calibrate the Cardiac Troponin I method on the Stratus® CS analyzer.
Rebecca S. Ayash
Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 10/21/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K983722
510(k) Number
signature
Division Sign-Off Office of Device Evaluation
ﻪ،ﺳﻪ
/ prescription use