(93 days)
Not Found
No
The summary describes a control material for an immunoassay analyzer and does not mention any AI or ML components or functions.
No
This device is described as an "assayed control" used for "calibration verification" and "verification of the assay range" of a HCG STAT reagent on immunoassay analyzers. It does not exert any direct therapeutic effect on 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 control product used to ensure the accuracy and reliability of an immunoassay analyzer, not to diagnose a patient's condition directly.
No
The device description clearly states it is a "lyophilized product consisting of HCG in human 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 clearly states it's for "calibration verification" and "verification of the assay range" for the Elecsys HCG STAT 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 HCG in human serum matrix." This is a biological material designed to be used in a laboratory setting for testing purposes.
- Function: Its function is to act as a control to ensure the accuracy and reliability of the Elecsys HCG STAT assay, which is itself an IVD test for measuring HCG.
Therefore, based on its intended use and description, the Elecsys HCG STAT CalCheck 5 fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elecsys HCG STAT 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 STAT 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 HCG STAT CalCheck 5 is a lyophilized product consisting of HCG in human 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 HCG STAT CalCheck 5 was evaluated for value assignment. Because Elecsys HCG STAT CalCheck 5 formulation is identical to the Elecsys HCG+B CalCheck 5, the stability studies presented and cleared in the HCG+ ß CalCheck 5 submission, K092168, apply
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
MAR - 4 2010
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
317-521-3577
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: November 30, 2009 | |
| Device Name | Proprietary name: Elecsys HCG STAT CalCheck 5
Common name: HCG STAT CalCheck 5
Classification name: Single (specified) analyte controls (assayed and
unassayed) | |
| Predicate
device | The Elecsys HCG STAT 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 HCG STAT CalCheck 5 is a lyophilized product consisting of
HCG in human serum matrix. During manufacture, the analyte is spiked into
the matrix at the desired concentration levels. | |
| Intended use | The Elecsys HCG STAT CalCheck 5 is an assayed control for use in
calibration verification and for use in the verification of the assay range
estabalished by the Elecsys HCG STAT reagent on the indicated Elecsys and
cobas e immunoassay analyzers. | |
| | Continued on next page | |
1
510(k) Summary, Continued
The table below compares Elecsys HCG STAT CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+B Calcheck 5 (K092168). .
| Characteristic | Elecsys HCG+β CalCheck 5
(K092168) | Elecsys HCG STAT 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 HCG STAT 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 STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Levels | Five | Five |
| Format | Lyophilized | Lyophilized |
| 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 hrs | Same |
| Matrix | Human serum matrix | Same |
Performance Characteristics
The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment. Because Elecsys HCG STAT CalCheck 5 formulation is identical to the Elecsys HCG+B CalCheck 5, the stability studies presented and cleared in the HCG+ ß CalCheck 5 submission, K092168, apply
2
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 an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three parallel, curved lines.
Roche Diagnostics Corp c/o Kelly C. O'Maine Adams 9115 Hague Road PO Box 50410 Indianapolis, Indiana 46250-0416 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
MAR 0 4 2010
K093700 Re:
Trade Name: ELECYS HCG STAT CALCHECK 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Calibrator. Regulatory Class: Class I Product Codes: JJX Dated: February 8, 2010 Received: February 12, 2010
Dear Ms. 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 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,
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):
i o937vr2
Device Name: Elecsys HCG STAT CalCheck 5
Indication For Use:
The Elecsys HCG STAT 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 STAT 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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 093700
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