(85 days)
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No
The document describes a calibrator for a diagnostic assay, which is a chemical product used for calibration, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is described as an "in vitro diagnostic product intended to be used to calibrate Opus™ Troponin I Test Modules" and contains "native human troponin complex in a buffered bovine protein matrix," indicating it is used for calibration in laboratory testing, not for directly treating a medical condition.
No
The device described is a calibrator for a diagnostic assay, not a diagnostic device itself. Its purpose is to calibrate a test that measures cardiac troponin I, ensuring the accuracy of the diagnostic measurement.
No
The device description clearly states it is a "six level frozen product" containing biological material, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states it is "an in vitro diagnostic product intended to be used to calibrate Opus™ Troponin I Test Modules."
- Device Description: Describes a product used to calibrate an assay for measuring a substance (cardiac troponin I) in human biological samples (serum and heparinized plasma). This is a core function of IVDs.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (Dimension® RxL Troponin I Calibrator) strongly suggests it is a medical device regulated by the FDA, and calibrators for diagnostic assays fall under the IVD category.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For calibration of the Opus™ Troponin I assay used for the quantitative measurement of cardiac troponin I in human serum and heparinized plasma.
The Opus™ Troponin I Calibrator is an in vitro diagnostic product intended to be used to calibrate Opus™ Troponin I Test Modules.
Product codes
JIT
Device Description
Opus™ Troponin I Calibrator is a six level frozen product with target concentrations of 0, 2, 8, 18, 25, 30, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of six vials packaged as one set.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Dimension® RxL Troponin I Calibrator
Reference Device(s)
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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).
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§ 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.
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JUL - 1 1999
Dade Behring
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
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: | 4/6/99 |
| Device Name: | Opus™ Troponin Calibrator |
| Classification Name: | Calibrator, secondary |
| Predicate Device: | Dimension® RxL Troponin I Calibrator |
Device Description: Opus™ Troponin I Calibrator is a six level frozen product with target concentrations of 0, 2, 8, 18, 25, 30, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of six vials packaged as one set.
Intended Use: For calibration of the Opus™ Troponin I assay used for the quantitative measurement of cardiac troponin I in human serum and heparinized plasma.
Comparison to Predicate Device:
| Opus™ Troponin I Calibrator | Dimension® RxI. Troponin I Calibrator | |
|---|---|---|
| Intended Use | calibrator | calibrator |
| Analyte | native human troponin complex | native human troponin complex |
| Matrix | buffered bovine protein | buffered bovine protein |
| Form | frozen | frozen |
| Volume | 1.0 mL per vial | 3.0 mL per vial |
| Values | assigned | assigned |
| Levels | 6 levels | 5 levels |
Comments on Substantial Equivalence: Both the Opus™ Troponin I Calibrator and the Dimension® RxL Troponin I Calibrator are manufactured using the same matrix and contain native human troponin complex as the analyte source. Both products are intended to be used as calibrators for cardiac troponin I assays.
1
Conclusion: The Opus™ Troponin I Calibrator is substantially equivalent to the Dimension® RxL Troponin I Calibrator based on the comparison summarized on the previous page.
Rebecca S. Ayash
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, layered on top of each other. The profiles are black against a white background.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 1 1999
Ms. Rebecca S. Ayash Regulatory Affairs and Compliance Manager DADE BEHRING INC. Glasgow Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714
Re: K991176
Trade Name: Opus™ Troponin I Calibrator Regulatory Class: II Product Code: JIT Dated: June 11, 1999 Received: June 15, 1999
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 against 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 vour device can be found in the Code of Federal Regulations, 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.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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 vours.
Steven Putman
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
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Indications Statement
K991176
Device Name: Opus™ Troponin I Calibrator
Indications for Use: The Opus™ Troponin I Calibrator is an in vitro diagnostic product intended to be used to calibrate Opus™ Troponin I Test Modules.
Stan Cooper
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
Clinical Laboratory Collin 510(k) Number
Rebecca S. Apsh
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99
ie -(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
Division Sign-Off Office of Device Evaluation
Prescription Use