(20 days)
Not Found
No
The summary describes a calibrator for a chemistry system, which is a standard laboratory reagent, and contains no mention of AI or ML.
No.
The device is an in vitro diagnostic product used for the calibration of a laboratory test and is not intended to treat or prevent disease.
Yes
The "Intended Use / Indications for Use" states it is "an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method". While it's a calibrator, it's explicitly part of a diagnostic process.
No
The device is a liquid, frozen, human serum based product, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based product containing native human troponin complex with other components designed to stabilize the product. The calibrator levels and their nominal values are: 0.00, 0.60, 6.00, 20.00, and 43.00 ng/mL.
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.
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510(k) Summary of Safety and Effectiveness LOCI® Cardiac Troponin I Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigncd 510(k) number is:
081683
1. Submitter's Contact Information and Date of Preparation
Mrs. Yuk-Ting Lewis Submitter's Contact Information: Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Tel: 302-631-7626
Date of Preparation:
June 12, 2008
Proprietary Device Name / FDA Classification Name 2.
LOCI® Cardiac Troponin I Calibrator / 21 CFR 862.1150
3. Identification of the Predicate Device
Dimension Vista® Cardiac Troponin I Calibrator, K053577
Device Description 4.
The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based product containing native human troponin complex with other components designed to stabilize the product. The calibrator levels and their nominal values are:
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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క. Device Intended Use
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.
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6. Summary of the devices technological characteristics
A comparison of the LOCI® Cardiac Troponin I Calibrator vs. the predicate device is provided.
| Feature | Predicate Device:
Dimension Vista® Cardiac
Troponin I Calibrator | New Device:
LOCI® Cardiac Troponin I
Calibrator |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CTNI CAL is an in vitro
diagnostic product for the
calibration of Cardiac Troponin
I (CTNI) on the Dimension
Vista system. | The LOCI® TNI CAL is an in
vitro diagnostic product for the
calibration of the Cardiac
Troponin I (TNI) method on the
Dimension® EXL™ integrated
chemistry system with LOCI®
module. |
| Analyte | Human troponin complex | |
| Matrix | Human serum | |
| Form | The calibrators are in a liquid, frozen form. | |
| Calibrator levels | The CTNI Calibrator kit
contains twelve (12) vials; two
at each level. The nominal
values are 0, 0.4, 4, 8, 20, and
41 ng/mL. | The LOCI® TNI Calibrator kit
contains ten (10) vials; two vials
at each level. The nominal
values are 0.00, 0.60, 6.00,
20.00, and 43.00 ng/mL. |
| Stability | The stability of the calibrators is established through real-time data
on 3 lots of product. Testing is conducted at multiple time points
and must pass pre-defined acceptance criteria. | |
| Traceability | The calibrator is traceable to an internal master pool containing
human cardiac troponin complex. | |
7. Conclusion
Based on a review of the devices technological features, the LOCI® Cardiac Troponin I Calibrator is substantially equivalent to the legally marketed device, the Dimension Vista® Cardiac Troponin I Calibrator.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis RA & Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714
JUL - 7 2008
Re: K081683 Trade/Device Name: LOCI® Cardiac Troponin I Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 13, 2008 Received: June 17, 2008
Dear Ms. Lewis:
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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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 (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
K081683 510(k) Number (if known):
Device Name: LOCI® Cardiac Troponin I Calibrator
Indications For Use:
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081683
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