(34 days)
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No
The document describes a control material for an immunoassay, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
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 a reagent, indicating it is an analytical control product for laboratory use, not a device intended for direct therapeutic intervention on a patient.
No
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 ensure the accuracy of a diagnostic test, rather than being a diagnostic test itself.
No
The device description clearly states it is a "lyophilized product consisting of synthetic osteocalcin 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 "verification of the assay range" for an Elecsys N-MID Osteocalcin reagent on immunoassay analyzers. This indicates it's used to assess the performance of a diagnostic test that measures a substance in a biological sample (osteocalcin).
- Device Description: It's a "lyophilized product consisting of synthetic osteocalcin in a human serum matrix." This describes a material designed to mimic a biological sample containing an analyte, which is characteristic of IVD controls or calibrators.
- Context: The device is used with "Elecsys and cobas e immunoassay analyzers," which are common platforms for performing in vitro diagnostic tests.
- Predicate Device: The predicate device listed (Elecsys DHEA-S CalCheck 5) is also a CalCheck product, which are typically used as controls or calibrators for IVD assays.
Therefore, the Elecsys N-MID Osteocalcin CalCheck 5 fits the definition of an IVD as it is a reagent or material intended for use in an in vitro diagnostic procedure to verify the performance of a diagnostic test.
N/A
Intended Use / Indications for Use
The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin 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 N-MID Osteocalcin CalCheck 5 is a lyophilized product consisting of synthetic osteocalcin in a 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
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Input Imaging Modality
Not Found
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 N-MID Osteocalcin CalCheck 5 was evaluated for value Performance Characteristics 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
| 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: Jane Phillips, PhD
Phone: 317-521-3338
Fax: 317-521-2324
Email: jane.phillips@roche.com
Secondary Contact: Kelly Colleen O'Maine Adams
Phone: 317-521-3577
Fax: 317-521-2324
Email: colleen.adams@roche.com
Date Prepared: July 15, 2011 | |
| Device Name | Proprietary name: Elecsys N-MID Osteocalcin CalCheck 5
Common name: Osteocalcin CalCheck 5
Classification name: Single (specified) analyte controls (assayed and
unassayed) | |
| Predicate
device | The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin CalCheck 5 is a lyophilized product
consisting of synthetic osteocalcin in a human serum matrix. During
manufacture, the analyte is spiked into the matrix at the desired concentration
levels. | |
| Intended use | The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated
Elecsys and cobas e immunoassay analyzers. | |
Continued on next page
1
510(k) Summary, Continued
Comparison Table The table below compares Elecsys N-MID Osteocalcin CalCheck 5 with the predicate device, Elecsys DHEA-S CalCheck 5 (K103402).
| Characteristic | Elecsys N-MID Osteocalcin
CalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5
(K103402) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Intended Use | The Elecsys N-MID Osteocalcin
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 N-MID Osteocalcin 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. |
| Stability | Reconstituted:
• 20-25°C: 5 hours | Reconstituted:
• 20-25°C: 4 hours |
| Analyte | Osteocalcin | DHEA-S |
| Similarities | | |
| 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 |
| Matrix | Human serum matrix | Same |
| Stability | Unopened:
• Store at 2-8°C until expiration
date | Unopened:
• Same |
The Elecsys N-MID Osteocalcin CalCheck 5 was evaluated for value Performance Characteristics assignment and stability.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle or bird-like figure, with its wings forming a flowing, abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/2/Picture/4 description: The image shows a date, AUG 2 5 2041, in bold black font. The month is abbreviated to AUG, followed by the day 2 and 5. The year is 2041. The date is likely extracted from a document or label.
Roche Diagnostics c/o Ms. Jane Ellen Phillips Program Manager, Regulatory Submissions 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250
Re: K112104 Trade Name: Elecsys N-MID Osteocalcin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Codes: JJX Dated: July 21, 2011 Received: July 22, 2011
Dear Ms. Phillips,
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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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.
Courtney 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 N-MID Osteocalcin CalCheck 5
Indications for Use:
The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112104
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