(53 days)
Not Found
No
The summary describes a calibration control product for an immunoassay analyzer, which is a chemical reagent used for quality control. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on value assignment and stability, not algorithmic performance.
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 diagnostic immunoassays. It does not treat or prevent disease.
No
The device is described as an "assayed control" used for calibration verification and assay range verification of other reagents and analyzers. It is not used to directly diagnose a patient's condition.
No
The device description explicitly states it is a "lyophilized product consisting of recombinant human insulin in bovine serum matrix," which is a physical substance, not software.
Based on the provided information, the 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 established by the Elecsys Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers." These are activities performed in vitro (outside the body) to ensure the accuracy and reliability of an in vitro diagnostic test (the Elecsys Insulin reagent).
- Device Description: The description mentions it's a "lyophilized product consisting of recombinant human insulin in bovine serum matrix." This is a laboratory reagent designed to be used with an immunoassay analyzer, which is a common type of IVD instrument.
- Performance Studies: The performance studies evaluate the device's "value assignment and Performance Characteristics stability," which are relevant to its function as a control for an IVD assay.
While the device itself is a control/calibrator, its purpose is directly tied to the performance and accuracy of an in vitro diagnostic test (the Elecsys Insulin assay). Therefore, it falls under the umbrella of IVD devices.
N/A
Intended Use / Indications for Use
The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys Insulin CalCheck 5 is a lyophilized product consisting of recombinant human insulin in 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 Insulin CalCheck 5 was evaluated for value assignment and Performance Characteristics stability. The data demonstrate that the performance of the Elecsys Insulin CalCheck 5 is substantially equivalent to that of the predicate device, Elecsys HCG+Beta CalCheck 5 (K092168).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Roche Diagnostics
Elecsys® Insulin CalCheck 5
| 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 | |||
| Indianapolis, IN 46250 | |||
| JUN 11 2010 | |||
| 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: April 16, 2010 | |||
| Device Name | Proprietary name: Elecsys® Insulin CalCheck 5 | ||
| Common name: Insulin CalCheck 5 | |||
| Classification name: Single (specified) analyte controls (assayed and | |||
| unassayed) | |||
| Predicate | |||
| device | The Elecsys Insulin CalCheck 5 is substantially equivalent to other products | ||
| in commercial distribution intended for similar use. We claim equivalency to | |||
| the currently marketed Elecsys HCG+B CalCheck 5 (K092168). | |||
| Device | |||
| Description | The Elecsys Insulin CalCheck 5 is a lyophilized product consisting of | ||
| recombinant human insulin in bovine serum matrix. During manufacture, the | |||
| analyte is spiked into the matrix at the desired concentration levels. | |||
| Intended use | The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e | |||
| immunoassay analyzers. | |||
Continued on next page
Confidential
Page 1 of 2
1
Roche Diagnostics
510(k) Summary, Continued
| Comparison | The table below compares Elecsys Insulin CalCheck 5 with the predicate |
|---|---|
| Table | device, Elecsys HCG+B Calcheck 5 (K092168). |
| Characteristic | Elecsys HCG+β CalCheck 5
(K092168) | Elecsys Insulin 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 Insulin 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 Insulin
reagent on the indicated Elecsys and
cobas e immunoassay analyzers. |
| Matrix | Human serum matrix | Bovine serum matrix |
| Levels | Five | Same |
| Format | Lyophilized | 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 |
The Elecsys Insulin CalCheck 5 was evaluated for value assignment and Performance Characteristics stability. Conclusion The data demonstrate that the performance of the Elecsys Insulin CalCheck 5 is substantially equivalent to that of the predicate device, Elecsys HCG+β CalCheck 5 (K092168).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES.USA
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Roche Diagnostics Corp. c/o Ms. Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road, PO Box 50410 Indianapolis, IN 46250-0416
JUN 1 1 2010
K101075 Re: Trade Name: Elecsys® Insulin CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: April 16, 2010 Received: April 19, 2010
Dear Ms. Baumann:
We have reviewed your Section 510(k) premarket notification of intent to market the we have formed your ood have determined the device is substantially equivalent (for de recolorenene 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 marketed in meetstate ovents, 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 with the provisions of thapproval application (PMA). You may, therefore, market the approvide of a promazions provisions of the Act. The general controls actives, subject to Act include requirements for annual registration, listing of devices, provisions of the ing 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 (1 Wrift), It may of basice 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 I fouse oo aa ADDA has made a determination that your device complies with other not firements 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 I coderal agencies: "Fou mast compy 1 CFR Part 807); labeling (21 CFR Parts 801 and 1111164 to: reporting (reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
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
Indications for Use Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Elecsys Insulin CalCheck 5
Indications for Use: The Elecsys Insulin 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 Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Over-The-Counter Use Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101075
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