(118 days)
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No
The document describes a control material for immunoassay analyzers and does not mention any AI or ML components.
No
This device is an assayed control used for calibration verification and to verify the assay range of a reagent, not for treating patients.
No
The device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HCG+B reagent". It is a control product used to verify the performance of other diagnostic devices (immunoassay analyzers), not a diagnostic device itself.
No
The device description explicitly 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 explicitly states it's for "calibration verification and for use in the verification of the assay range established by the Elecsys HCG+B reagent on the indicated Elecsys and cobas e immunoassay analyzers." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys HCG+B reagent).
- Device Description: The description mentions it's a "lyophilized product consisting of HCG in human serum matrix." This is a biological material used as a control in a laboratory setting.
- Predicate Device: The mention of a predicate device (K010237; Elecsys HCG+$\beta$ CalCheck) which is also a CalCheck product, further supports its classification as an IVD. CalChecks are a common type of IVD used for quality control in diagnostic testing.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and nature of the product clearly align with the definition of an IVD. It's a reagent used in a laboratory setting to ensure the accuracy and reliability of a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Elecsys HCG+B CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the reportable range established by the Elecsys HCG+β 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+β 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
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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 HCG+B CalCheck 5 was evaluated for value assignment and stability.
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
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
317-521-3952
NOV 1 6 2009
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: July 16, 2009 |
| Device Name | Proprietary name: Elecsys HCG+$\beta$ CalCheck 5
Common name: HCG+$\beta$ CalCheck 5
Classification name: Single (specified) analyte controls (assayed and
unassayed) |
| Predicate
device | The Elecsys HCG+$\beta$ CalCheck 5 is substantially equivalent to other products
in commercial distribution intended for similar use. We claim equivalency to
the currently marketed Elecsys HCG+$\beta$ CalCheck (K010237). |
| Device
Description | The Elecsys HCG+$\beta$ 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+ $\beta$ CalCheck 5 is an assayed control for use in calibration
verification and for use in the verification of the reportable range established
by the Elecsys HCG+$\beta$ reagent on the indicated Elecsys and cobas e
immunoassay analyzers. |
:
15092168
.
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510(k) Summary, Continued
1
The table below compares Elecsys HCG+B CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+β Calcheck (K010237).
| Characteristic | Elecsys HCG+β CalCheck
(K010237) | Elecsys HCG+β CalCheck 5 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the verification of the
calibration established by the
Elecsys HCG+β reagent on Elecsys
1010 or 2010 immunoassay
analyzers. | The Elecsys HCG+ β CalCheck 5 is
an assayed control for use in
calibration verification and for use
in the verification of the reportable
range established by the Elecsys
HCG+β reagent on the indicated
Elecsys and cobas e immunoassay
analyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1 and Check 2
with exactly 1.0 mL distilled or
deionized water. Reconstitute
Check 3 with exactly 1.5 mL
distilled or deionized water. Allow
to stand closed for 15 minutes, then
mix gently by inversion. | 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. |
| 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+B CalCheck 5 was evaluated for value assignment and stability.
.
·
· .
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics c/o Ms. Sarah Baumann 9115 Hague Road, P.O. Box 50410 Indianapolis, IN 46250-0416
NOV 1 6 2009
Re: K092168
Trade/Device Name: Elecsys hCG+B 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: October 20, 2009 Received: October 21, 2009
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 class II (Special Controls), 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
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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
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Indication for Use
1092168 510(k) Number (if known):
Device Name: Elecsys HCG+B CalCheck 5
Indication For Use:
The Elecsys HCG+B 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+B 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 Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092168