(70 days)
Not Found
No
The summary describes a control material for an immunoassay, not a device that processes data or images using AI/ML.
No.
This device is described as an "assayed control" used for "calibration verification" and "verification of the assay range" of a reagent on immunoassay analyzers. It is a control product for laboratory testing, not a device intended to treat, diagnose, or prevent disease in a patient.
No
Explanation: The device is described as an "assayed control" used for "calibration verification" and "verification of the assay range" of another reagent. This indicates it is used to check the performance and accuracy of a diagnostic test, rather than performing a diagnosis itself.
No
The device description explicitly states it is a "lyophilized product consisting of prolactin in an equine serum matrix," indicating it is a physical reagent, not software.
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 Prolactin II reagent on immunoassay analyzers. This means it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: It's a "lyophilized product consisting of prolactin in an equine serum matrix." This is a biological material designed to be used in a laboratory setting for testing purposes.
- Context: The entire document describes a product used in conjunction with an immunoassay analyzer (which is an IVD device itself) to ensure the accuracy and reliability of the diagnostic results.
While it's a control material rather than a test that directly diagnoses a condition, control materials used to verify the performance of diagnostic tests are considered IVDs.
N/A
Intended Use / Indications for Use
The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys Prolactin II CalCheck 5 is a lyophilized product consisting of prolactin in an equine 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 Prolactin II CalCheck 5 was evaluated for value assignment and Characteristics stability.
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
510(k) Summary
ﺎ،
| 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 |
| | 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: March 2, 2011 |
| Device Name | Proprietary name: Elecsys Prolactin II CalCheck 5
Common name: Prolactin II CalCheck 5
Classification name: Single (specified) analyte controls (assayed and
unassayed) |
| Predicate
device | The Elecsys Prolactin II CalCheck 5 is substantially equivalent to other
products in commercial distribution intended for similar use. We claim
equivalency to the cleared Elecsys DHEA-S CalCheck 5 (K103402). |
| Device
Description | The Elecsys Prolactin II CalCheck 5 is a lyophilized product consisting of
prolactin in an equine serum matrix. During manufacture, the analyte is
spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and
cobas e immunoassay analyzers. |
| | Continued on next page |
1
510(k) Summary, Continued
The table below compares Elecsys Prolactin II CalCheck 5 with the predicate Comparison Table device, Elecsys DHEA-S CalCheck 5 (K103402).
| Characteristic | Elecsys Prolactin II CalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5 (K103402) |
|---|---|---|
| Intended Use | The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers. | The Elecsys DHEA-S 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 DHEA-S reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Analyte | Prolactin | DHEA-S |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion. | Same |
| Stability | Unopened: | |
| • Store at 2-8°C until expiration date | ||
| Reconstituted: | ||
| • 20-25°C: 4 hours | Unopened: | |
| • Same | ||
| Reconstituted: | ||
| • Same | ||
| Matrix | Equine serum matrix | Human serum matrix |
Performance The Elecsys Prolactin II CalCheck 5 was evaluated for value assignment and Characteristics stability.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's role in protecting and promoting the health and well-being of the nation.
Re:
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 1 2 2011
Roche Diagnostics Corp. c/o Ms. Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road, Bldg. A Indianapolis, Indiana 46250-0416
K110613 Trade Name: Elecsys Prolactin II Calcheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: I, reserved Product Codes: JJX Dated: March 02, 2011 Received: March 03, 2011
Dear Ms. O'Maine Adams:
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); medical device 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 Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courthey 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
KII0613 510(k) Number (if known):
Device Name: Elecsys Prolactin II CalCheck 5
Indication For Use:
The Elecsys Prolactin II 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 Prolactin II 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 (OVD)
Ous
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K-110613