(30 days)
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No
The document describes a control material for calibrating and verifying immunoassay analyzers, not a device that processes data or makes decisions using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is described as an assayed control for calibration verification and assay range verification of a reagent, not for treating any medical condition or disease.
No
Explanation: This device is described as an "assayed control" used for calibration verification and assay range verification for an immunoassay reagent, not for diagnosing a patient condition.
No
The device description clearly states it is a "lyophilized product consisting of recombinant human cardiac Troponin I in human serum matrix," indicating it is a physical substance, not software.
Based on the provided information, the Elecsys Troponin I CalCheck 5 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "calibration verification and for use in the verification of the assay range established by the Elecsys Troponin I reagent on the indicated Elecsys and cobas e immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys Troponin I reagent).
- Device Description: It's a "lyophilized product consisting of recombinant human cardiac Troponin I in human serum matrix." This is a reagent or control material used in laboratory testing.
- Performance Studies: The performance studies evaluate its "value assignment and stability," which are typical characteristics assessed for IVD control materials.
- Predicate Device: The predicate device is another "CalCheck" product, which are commonly used as controls in IVD testing.
The purpose of this device is to ensure the accuracy and reliability of an in vitro diagnostic test (the Elecsys Troponin I assay). Therefore, it falls under the definition of an IVD device.
N/A
Intended Use / Indications for Use
The Elecsys Troponin I CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin I reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys Troponin I CalCheck 5 is a lyophilized product consisting of recombinant human cardiac Troponin I in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
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)
The Elecsys Troponin I CalCheck 5 was evaluated for value assignment and stability.
The data demonstrate that the performance of the Elecsys Troponin I CalCheck 5 is substantially equivalent to that of the predicate device, Elecsys HCG+β CalCheck 5 (K092168).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Roche Diagnostics
KL00594
d t,
Elecsys Troponin I CalCheck 5
510(k) Summary
APR - 1 2010
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250 |
| | Contact Person: Sarah Baumann
Phone: 317-521-3952
Fax: 317-521-2324
Email: sarah.baumann@roche.com |
| | Secondary Contact: Stephanie Greeman
Phone: 317-521-2458
Fax: 317-521-2324
Email: stephanie.greeman@roche.com |
| | Date Prepared: March 1, 2010 |
| | Device Name |
| Predicate
device | The Elecsys Troponin I CalCheck 5 is substantially equivalent to other
products in commercial distribution intended for similar use. We claim
equivalency to the currently marketed Elecsys HCG+β CalCheck 5
(K092168). |
| Device
Description | The Elecsys Troponin I CalCheck 5 is a lyophilized product consisting of
recombinant human cardiac Troponin I in human serum matrix. During
manufacture, the analyte is spiked into the matrix at the desired concentration
levels. |
| Intended use | The Elecsys Troponin I CalCheck 5 is an assayed control for use in
calibration verification and for use in the verification of the assay range
established by the Elecsys Troponin I reagent on the indicated Elecsys and
cobas e immunoassay analyzers. |
| | Continued on next page |
1
510(k) Summary, Continued
The table below compares Elecsys Troponin I CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+β Calcheck 5 (K092168).
| Characteristic | Elecsys HCG+β CalCheck 5
(K092168) | Elecsys Troponin I CalCheck 5 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys HCG+β CalCheck 5 is
an assayed control for use in
calibration verification and for use in
the verification of the assay range
established by the Elecsys HCG+β
reagent on the indicated Elecsys and
cobas e immunoassay analyzers. | The Elecsys Troponin I CalCheck 5 is
an assayed control for use in
calibration verification and for use in
the verification of the assay range
established by the Elecsys Troponin I
reagent on the indicated Elecsys and
cobas e immunoassay analyzers. |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Matrix | Human serum matrix | Same |
| Handling
instructions | Reconstitute the contents of
each vial with exactly 1.0 mL distilled
or deionized water.
Allow the bottle to stand closed for 15
minutes. Mix gently by inversion to
ensure homogeneity. | Same |
| Stability | Unopened:
• Store at 2-8°C until expiration date
Reconstituted:
• 20 – 25°C : 4 hrs | Same |
| Performance | Characteristics | The Elecsys Troponin I CalCheck 5 was evaluated for value assignment and stability. |
|---|---|---|
| Conclusion | The data demonstrate that the performance of the Elecsys Troponin I | |
| CalCheck 5 is substantially equivalent to that of the predicate device, | ||
| Elecsys HCG+β CalCheck 5 (K092168). |
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and a wavy base.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics c/o Sarah Baumann Regulatory Affairs Consultant Roche Professional Diagnostics 9115 Hague Road, P.O. Box 50410 Indianapolis, IN 46250-0416, USA
APR 0 1 2010
Re: K100594 Elecsys Troponin I CalCheck 5 Trade/Device Name: Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: March 1, 2010 Received: March 2, 2010
Dear Ms. Baumann
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).
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney C. Harper, Ph.D. 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
510(k) Number (if known):
Device Name: Elecsys Troponin I CalCheck 5
Indication For Use:
The Elecsys Troponin I CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin I reagent on the indicated Elecsys and cobas e immunoassay analyzers.
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
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100594