(131 days)
No
The document describes a control material for an immunoassay, not a device that processes data or makes decisions using AI/ML. The performance studies focus on value assignment and stability, not algorithmic performance.
No
This device is an assayed control for in vitro diagnostic use, specifically for calibration verification and verification of assay range. It is not intended for treating, diagnosing, or preventing diseases in patients.
No
This device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range" of a diagnostic reagent. It is used to ensure the proper functioning of diagnostic instruments, not to directly diagnose a disease.
No
The device is a lyophilized product consisting of CA 15-3 in a serum matrix, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostics use only."
This statement, along with the description of the device as a control used in calibration verification and assay range verification for an immunoassay, clearly indicates that it is intended for use in laboratory testing of samples taken from the human body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Elecsys CA 15-3 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 CA 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys CA 15-3 II CalCheck 5 is a lyophilized product consisting of CA 15-3 in equine serum matrix (Level 1) or human serum matrix (Levels 2-5). 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 CA 15-3 II CalCheck 5 was evaluated for value assignment and stability.
Value Assignment: Value assignment testing was conducted and must pass pre-defined acceptance criteria. For each Elecsys CA 15-3 II CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three E170 analyzer measuring cells. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzer measuring cells) of the respective CalCheck. The target value for each CalCheck is the median value obtained over at least 6 determinations of the respective CalCheck. The assigned range is calculated as +/-21% of the assigned value for levels 2 through 5, while level 1 is assigned as a value
§ 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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长122242
510(k) Summary
DEC 5 2012 -
| 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: Edie Eads | |
| Phone: 317-521-4668 | |
| Fax: 317-521-2324 | |
| Email: edie.eads@contractors.roche.com | |
| Secondary Contact: Stephanie Greeman | |
| Phone: 317-521-2458 | |
| Fax: 317-521-2324 | |
| Email: stephanie.greeman@roche.com | |
| Date Prepared: July 24, 2012 | |
| Device Name | Proprietary name: Elecsys CA 15-3 II CalCheck 5 |
| Common name: CA 15-3 II CalCheck 5 | |
| Classification: 21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed) | |
| Product Code: JJX | |
| Predicate device | The Elecsys CA 15-3 II CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys CA 19-9 CalCheck 5 (K101365). |
| Device Description | The Elecsys CA 15-3 II CalCheck 5 is a lyophilized product consisting of CA 15-3 in equine serum matrix (Level 1) or human serum matrix (Levels 2-5). During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
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:
Continued on next page
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1
Intended use The Elecsys CA 15-3 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 CA 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only. :
| Comparison | The table below compares Elecsys CA 15-3 II CalCheck 5 with the predicate | |
|---|---|---|
| Table | devices, Elecsys CA 19-9 CalCheck 5 (K101365), |
| Characteristic | Elecsys CA 15-3 II CalCheck 5
(Candidate) | Elecsys CA 19-9
CalCheck 5 (K101365) | Elecsys CA 15-3 CalSet
(K001468) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys CA 15-3 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 CA 15-3 II reagent
on the indicated Elecsys and
cobas e immunoassay analyzers.
For in vitro diagnostics use only. | The Elecsys CA 19-9
CalCheck 5 is an assayed
control for the use in
calibration verification and
for use in the verification of
the assay range established
by the Elecsys CA 19-9
reagent on the indicated
Elecsys and cobas e
immunoassay analyzers. | Elecsys CA 15-3 CalSet is
used for calibrating the
quantitative Elecsys CA 15-3
assay on Elecsys 1010 or 2010
immunoassay systems. |
| Analyte | CA 15-3 | CA 19-9 | CA 15-3 |
| Matrix | Human serum, equine serum
(Level 1) | Human Serum | Human Serum |
| Levels | Five | Same | Two |
| Format | Lyophilized | Same | NA |
| 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, and then
mix gently by inversion. | Same | The calibrators are supplied
ready for use in bottles that are
compatible with the system.
The calibrators should only be
left on the analyzers during
calibration at 20-25°C. After
use, close the bottles as soon
as possible and store at 2-8°C.
Because of possible
evaporation effects, not more
than 5 calibration procedures
per bottle set should be
performed. |
| Stability | Unopened:
Store at 2-8°C until expiration
date
Opened:
20-25°C: 4 hours | Same | Unopened:
Same
Opened:
Twelve weeks at 2-8°C
On the analyzers:
Up to five hours in total |
Continued on next page
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510(k) Summary, Continued
Performance The Elecsys CA 15-3 II CalCheck 5 was evaluated for value assignment and Characteristics stability. See the following sections for details. Value Value assignment testing was conducted and must pass pre-defined Assignment acceptance criteria. For each Elecsys CA 15-3 II CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three E170 analyzer measuring cells. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzer measuring cells) of the respective CalCheck. The target value for each CalCheck is the median value obtained over at least 6 determinations of the respective CalCheck. The assigned range is calculated as ±21% of the assigned value for levels 2 through 5, while level 1 is assigned as a value ≤ 2.5 U/mL. The % CV is 5% for levels 2 through 5. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use. To ensure the values assigned using the master platform are transferrable and valid for the other instrument platforms, the same value assignment procedure is performed on the Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 analyzers. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICES E170. The median value obtained on the four additional analyzers must be within 10% of the master platform assigned value (10% for between analyzer platform tolerances). After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the MODULAR ANALYTICS E170, Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers. Stability Real-time and accelerated stability tests were conducted to establish the shelflife and open-vial claims. Open-Vial Stability After Reconstitution: Real-time testing was performed and the data support the package insert claim that reconstituted Elecsys CA 15-3 II CalCheck 5 is stable up to 4 hours at 20-25°C. Shelf-Life Stability: The accelerated stability testing performed at 35°C supports an initial shelf-life claim of 18 months at 2-8℃. Real-time testing at 2-8℃ is on-going to support a claim of 36 months.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Date: December 5, 2012
Roche Diagnostics C/O Ms. Edie Eads Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250-0416
Re: K122242
Trade/Device Name: Elecsys CA 15-3 II CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: November 02, 2012 Received: November 05, 2012
Dear Ms. Eads:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Edie Eads
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria M. Chan
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR)
Center for Devices and Radiological Health
5
Indication for Use
510(k) Number (if known): K122242
Device Name: Elecsys CA 15-3 II CalCheck 5
Indication for Use:
The Elecsys CA 15-3 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 CA 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only.
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)
Maria M. Chow
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K122242