(49 days)
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No
The document describes a calibration control product for an immunoassay analyzer, which is a chemical reagent used for quality control, not a device that processes data or makes decisions using AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is an assayed control used for calibration verification and assay range verification of a reagent, not for treating a disease or condition.
No
This device is described as an "assayed control for use in calibration verification" and "verification of the assay range," which means it is used to check the performance of an immunoassay analyzer rather than directly diagnosing a patient's condition.
No
The device description clearly states it is a "lyophilized product consisting of DHEA-S in a human 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 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." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys DHEA-S reagent).
- Device Description: It's a "lyophilized product consisting of DHEA-S in a human serum matrix." This is a biological material designed to be used in a laboratory setting with diagnostic equipment.
- Predicate Device: The predicate device listed, "Elecsys C-Peptide CalCheck 5," is also a CalCheck product, which are typically IVD controls used for calibration and quality control of diagnostic assays.
The purpose of this device is to ensure the accuracy and reliability of an in vitro diagnostic test (the Elecsys DHEA-S assay). This directly aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys DHEA-S CalCheck 5 is a lyophilized product consisting of DHEA-S in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 DHEA-S 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.
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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 | |
| | 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: December 28, 2010 | |
| Device Name | Proprietary name: Elecsys DHEA-S CalCheck 5
Common name: DHEA-S CalCheck 5
Classification name: Single (specified) analyte controls (assayed and
unassayed) | |
| Predicate
device | The Elecsys DHEA-S CalCheck 5 is substantially equivalent to other
products in commercial distribution intended for similar use. We claim
equivalency to the currently marketed Elecsys C-Peptide CalCheck 5
(K100810). | |
| Device
Description | The Elecsys DHEA-S CalCheck 5 is a lyophilized product consisting of
DHEA-S in a human serum matrix. During manufacture, the analyte is spiked
into the matrix at the desired concentration levels. | |
| Intended use | 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. | |
Continued on next page
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- 510(k) Summary, Continued
The table below compares Elecsys DHEA-S CalCheck 5 with the predicate Comparison Table device, Elecsys C-Peptide CalCheck 5 (K100810).
| Characteristic | Elecsys C-Peptide CalCheck 5
(K100810) | Elecsys DHEA-S CalCheck 5
(Candidate Device) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys C-Peptide CalCheck 5 is an
assayed control for use in calibration
verification and for use in the verification
of the serum and plasma assay range
established by the Elecsys C-Peptide
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 | C-Peptide | 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 Characteristics
י ")
The Elecsys DHEA-S 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 stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA."
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Roche Diagnostics
Roche Professional Diagnostics c/o Ms. Kelly Colleen O' Maine Adams Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Jan 0 7 2011
Re: K103402 Trade Name: Elecsys DHEA-S 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: November 18, 2010 Received: November 19, 2010
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).
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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,
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
Indication for Use
510(k) Number (if known):
JAN - 7 2011
Device Name: Elecsys DHEA-S CalCheck 5
Indication For Use:
The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibration verification
for the same of the and and and stablished by the Flective DHFA-S The Elecsys DHEA-S CalCheck J is an assay range established by the Elecsys DHEA-S
and for use in the verification of the assay range established by the Elecsys on buyers and for use in the vertricultion of the active immunoassay analyzers.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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) k/03402