(41 days)
Not Found
No
The summary describes a liquid control product for immunoassay analyzers and contains no mention of AI or ML.
No
The device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range" of Elecsys Digoxin reagent. It is an in vitro diagnostic (IVD) control material, not a device used for treating a patient.
No
The device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range". It is a product used to ensure the accuracy of other diagnostic devices (Elecsys Digoxin reagent on immunoassay analyzers) and does not directly diagnose a patient's condition.
No
The device description explicitly states it is a "liquid product consisting of Digoxin in a buffer/protein (bovine serum) matrix," indicating it is a physical reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration verification" and "verification of the assay range" for the Elecsys Digoxin reagent on immunoassay analyzers. These are activities performed in vitro (outside the body) to ensure the accuracy and reliability of a diagnostic test.
- Device Description: The description details a liquid product containing Digoxin in a buffer/protein matrix. This is a typical format for a control or calibrator used in laboratory testing.
- Context: The device is used in conjunction with the "Elecsys Digoxin reagent" and "Elecsys and cobas e immunoassay analyzers." These are all components of an in vitro diagnostic system used to measure Digoxin levels in patient samples.
- Predicate Device: The mention of a predicate device (K973973; Elecsys Digoxin CalCheck) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
The fact that it doesn't mention image processing, AI, anatomical site, patient age, or specific performance metrics like sensitivity and specificity is consistent with it being a control/calibrator product, which is a type of IVD used to ensure the performance of the primary diagnostic test.
N/A
Intended Use / Indications for Use
The Elecsys Digoxin 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 Digoxin 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 Digoxin CalCheck 5 is a liquid product consisting of Digoxin in a buffer/protein (bovine serum) matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
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)
The Elecsys Digoxin CalCheck 5 was evaluated for value assignment and stability.
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
§ 862.1660 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
510(k) Summary
| 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, P.O. Box 50416 | ||
| Indianapolis, IN 46250-0416 | ||
| 317-521-3501 | AUG 3 1 2010 | |
| Contact Person: Kelly Colleen O'Maine Adams | ||
| Phone: 317-521-3577 | ||
| Fax: 317-521-2324 | ||
| Email: colleen.adams@roche.com | ||
| Secondary Contact: Stephanie Greeman | ||
| Phone: 317-521-2458 | ||
| Fax: 317-521-2324 | ||
| Email: stephanie.greeman@roche.com | ||
| Date Prepared: July 20, 2010 | ||
| Device Name | Proprietary name: Elecsys Digoxin CalCheck 5 | |
| Common name: Digoxin CalCheck 5 | ||
| Classification name: Single (specified) analyte controls (assayed and unassayed) | ||
| Predicate device | The Elecsys Digoxin CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys Digoxin CalCheck (K973973). | |
| Device Description | The Elecsys Digoxin CalCheck 5 is a liquid product consisting of Digoxin in a buffer/protein (bovine serum) matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. | |
| Intended use | The Elecsys Digoxin 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 Digoxin reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
Continued on next page
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510(k) Summary, Continued
The table below compares Elecsys Digoxin CalCheck 5 with the predicate Comparison Table device, Elecsys Digoxin CalCheck (K973973).
| Characteristic | Elecsys Digoxin CalCheck 5
(Candidate Device) | Elecsys Digoxin CalCheck
(K973973) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Digoxin 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 Digoxin
reagent on the indicated Elecsys and
cobas e immunoassay analyzers. | For use in the verification of the
calibration established by the Elecsys
Digoxin reagent on the indicated
Elecsys and cobas e immunoassay
analyzers. |
| Analyte | Digoxin | Digoxin |
| Levels | Five | Three |
| Format | Liquid | Liquid |
| Handling | Mix gently by inversion to ensure
homogeneity. | Mix gently by inversion to ensure
homogeneity. |
| Stability | Unopened:
• Store at 2-8°C until expiration date
Opened:
• 20-25°C: 6 hours | Unopened:
• Store at 2-8°C until expiration date
Opened:
• 15-25°C: 5 hours |
| Matrix | Bovine serum matrix | Bovine serum matrix |
Performance Characteristics The Elecsys Digoxin CalCheck 5 was evaluated for value assignment and stability. ·
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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, rendered in black. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flow.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Professional Diagnostics Ms. Kelly Colleen O'Maine Adams 9115 Hague Road Indianapolis, IN 46250-0416
Re: K102044
AUG 3 1 2010
Trade/Device Name: Elecsys Digoxin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: 20 July, 2010 Received: 21 July, 2010
Dear Ms. Adams:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained 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 Americal Coloral Food. Days commerce proc to May 20, 1970, the enaoutines with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval applicians of the Act . The and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merelore, market the device, becares for annual registration, listing of
general controls provisions of the Act include requirements for annual registration and general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) mis one stice can be found in Title 21, additional controls. Existing major regulations asonaly of the may publish further
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further Couc of Pedoral Regaration your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a subscribes with other requirements of the Act
that FDA has made a determination that your device areasies. You must that FDA has made a delemination inal your devices by other Federal agencies. You must or any Federal statules and regulations and including, but not limited to: registration and listing (2 l
earing of comply with all the Act S requirements, medical device reporting (reporting of
CFR Part 807); labeling (21 CFR Parts (11 am 800); and anonvifiesturing practice CFR Part 807); labeling (21 CFR 803); and good manufacturing practice medical device-related adverse evelis) (21 CER OS), and giove and requirements as set form in the quality systems (10) rour Section 510(k) premarket
will allow you to begin marketing your device as described in your Section 510 a legally ma will allow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of thus parmits your device to notitication. The FDA Inding of substantial equivalise of this, permits your device to proceed to the market.
3
Page 2
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
AC
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):
K1020
Device Name: Elecsys Digoxin CalCheck 5
Indication For Use:
The Elecsys Digoxin 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 Digoxin 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)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102044
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