(82 days)
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Not Found
No
The summary describes a calibrator for an in vitro diagnostic test, which is a chemical reagent used to establish reference points. There is no mention of any computational or algorithmic processing that would suggest AI/ML.
No.
The device is an in vitro diagnostic product used for calibration in D-dimer concentration determination, not for directly treating a disease or condition.
No
This device is described as a "calibrator", which is used to calibrate an existing diagnostic method/analyzer. It does not directly perform diagnosis itself.
No
The device description explicitly states it consists of a plastic cartridge containing liquid, indicating it is a physical component and not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "in vitro diagnostic product".
- Function: It is used to calibrate a method for determining D-dimer concentration in human specimens, which is a diagnostic test performed outside the body (in vitro).
- Device Description: It is a component used with an analyzer to perform this in vitro test.
N/A
Intended Use / Indications for Use
The Stratus® CS D-dimer CalPak is an in vitro diagnostic product used to calibrate the Stratus® D-dimer method on the Stratus® CS STAT fluorometric analyzer. This calibrator is intended for medical purposes to establish points of reference that are used in the determination of D-dimer concentration in human specimens.
Product codes
DAP; GHH; JIT
Device Description
The Stratus® CS D-dimer CalPak consists of a plastic cartridge (CalPak) containing human D-dimer in a liquid, buffered bovine protein matrix in each of three wells. The CalPak is designed for use only on the Stratus® CS analyzer
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)
VIDAS® D-dimer (DD) Calibrator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
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KO22927
NOV 2 7 2002
Summary of Safety and Effectiveness Information
Stratus® CS D-dimer CalPak (calibrator)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.
| Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | September 4, 2002 |
| Name of Product: | Stratus® CS D-dimer CalPak (calibrator) |
| FDA Classification Name: | Calibrator (21 CFR§862.1150); DAP |
| Predicate Device: | VIDAS® D-dimer (DD) Calibrator |
| Device Description: | The Stratus® CS D-dimer CalPak consists of a plastic cartridge
(CalPak) containing human D-dimer in a liquid, buffered bovine
protein matrix in each of three wells. The CalPak is designed
for use only on the Stratus® CS analyzer |
| Intended Use: | The Stratus® CS D-dimer CalPak is an in vitro diagnostic
product used to calibrate the Stratus® D-dimer method on the
Stratus® CS STAT fluorometric analyzer. |
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Comparison to Predicate Device:
| | Stratus®CS
D-dimer CalPak | VIDAS® D-dimer
Calibrator |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Calibration of the Stratus®
D-dimer method | Calibration of the VIDAS®
D-dimer method |
| Form: | Liquid, stored frozen | Lyophilized |
| Matrix: | Buffered bovine protein
matrix with human D-dimer,
stabilizers and sodium azide | Lyophilized fibrin degradation
product from human plasma
with glycine-albumin bovine
buffer and sodium azide. |
| Package: | Sealed plastic cartridge for use
only on the Stratus® CS analyzer | Vials; 2 mL reconstituted |
| Calibration: | Calibration curve updated for each
lot initially, in triplicate and every
60 days thereafter using Master lot
values. After completion of each test,
the recovered values are automatically
calculated from the stored calibration
coefficients. | One point calibration tested in
duplicate, with each Master lot
initially by the user. Afterwards,
the user recalibrates every 14 days. |
Comments on Substantial Equivalence:
Both the Dade Behring Stratus® CS D-dimer CalPak and the VIDAS® D-dimer calibrator products are intended to calibrate their respective closed system methods utilizing similar designs consisting of human blood products in a buffered, bovine protein-based matrix.
Conclusion:
The Stratus® CS D-dimer CalPak is substantially equivalent in intended use and design to the VIDAS® D-dimer calibrator as noted above.
RM Vaught
Richard M. Vaught Regulatory Affairs and Compliance Manager September 4, 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is composed of three curved lines that resemble a bird in flight or a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 7 2002
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500. MS 514 P.O. Box 6101 Newark, DE 19714
K022977 · Re:
Trade/Device Name: Stratus® CS D-dimer CalPak (calibrator) Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP; GHH; JIT Dated: October 30, 2002 Received: November 15, 2002
Dear Mr. Vaught:
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Device Name:
Koza997
Stratus® CS D-dimer CalPak (calibrator)
Indications for Use:
The Stratus® CS D-dimer CalPak is an in vitro diagnostic product used to calibrate the Stratus® D-dimer method on the Stratus® CS STAT fluorometric analyzer. This calibrator is intended for medical purposes to establish points of reference that are used in the determination of D-dimer concentration in human specimens.
Rm Van ht
Richard M. Wright
ichard M. Vaught Regulatory Affairs and Compliance Manager
September 4, 2002
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Reeves for J. Bautista
Division Division of Clinical 510(k) Number
Prescription Use > (Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)