(142 days)
Not Found
No
The summary describes a calibration set for an immunoassay, which is a chemical reagent product, not a software or hardware device that would typically incorporate AI/ML. The description focuses on the composition and performance of the calibrator itself.
No
The device is a calibrator for an immunoassay, not a device used to treat a condition or disease.
No
This device is a calibrator, used to ensure the accuracy of an assay, not for directly diagnosing medical conditions.
No
The device description clearly states it is a lyophilized product consisting of human CA 125 in a 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 is used for calibrating a quantitative assay (Elecsys CA 125 II assay) on immunoassay analyzers. This assay is used to measure a substance (CA 125) in a sample (likely blood or serum, given the matrix description) to provide information about a patient's health.
- Device Description: The description mentions it's a lyophilized product consisting of human CA 125 in a serum matrix. This indicates it's a reagent or calibrator used in a laboratory setting to perform a diagnostic test on a biological sample.
- Performance Studies: The summary of performance studies mentions evaluation for value assignment, stability, and reconstitution, which are typical evaluations for IVD calibrators.
- Predicate Device: The mention of a predicate device (K003969; CA 125 CalSet) further confirms its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
The core function of this device is to ensure the accuracy of an in vitro diagnostic test, making it an integral part of the IVD process.
N/A
Intended Use / Indications for Use
CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II assay on the Elecsys and cobas e immunoassay analyzers.
Product codes
JIT
Device Description
The CA 125 II CalSet II is a lyophilized product consisting of human CA 125 in an equine (Cal 1) and a human (Cal 2) 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
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Summary of Performance Studies
The CA 125 II CalSet II was evaluated for value assignment, stability, and reconstitution. The data demonstrate that the performance of the CA 125 II CalSet II is substantially equivalent to that of the predicate device, Elecsys® CA 125 II CalSet.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K14/0112
JUN 0 6 2014
510(k) Summary
Device Name
| Proprietary name: | CA 125 II CalSet 11 |
|---|---|
| Common name: | CA 125 II CalSet II |
| Classification name: | Calibrator, secondary |
For the CA 125 II CalSet II, the establishment registration number (Roche Diagnostics GmbH Mannheim) is 9610126. The establishment registration
Diagnostics Only Internation United States is 1823260. Registration
Classification The FDA has classified the product as a Class II device.
| Panel | Product
Code | Classification Name | Regulation
Citation |
|--------------------|-----------------|-----------------------|------------------------|
| Clinical Chemistry | JIT | Calibrator, Secondary | 862.1150 |
| Predicate
Device | The CA 125 II CalSet II is substantially equivalent to other products in
commercial distribution intended for similar use. We claim equivalency to
the currently marketed CA 125 CalSet (K003969). |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The CA 125 II CalSet II is a lyophilized product consisting of human CA 125
in an equine (Cal 1) and a human (Cal 2) serum matrix. During manufacture,
the analyte is spiked into the matrix at the desired concentration levels. |
| Intended Use | CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II
assay on the Elecsys and cobas c immunoassay analyzers. |
| Reason for
Submission | The CA 125 II CalSet II is being changed from a liquid to lyophilized
material. In addition, we are decreasing the concentration of Cal 1 to 0 U/mL
by using equine serum. |
Continued on next page
1
510(k) Summary
Table 1 below compares CA 125 II CalSet II with the predicate device, CA Comparison 125 II CalSct (K003969). Table
Changes in the new product include lowering Cal 1 to no CA 125 (by using equine serum), and going from liquid calibrators to lyophilized.
Table 1. Comparison of Candidate and Predicate Devices
| Characteristic | CA 125 II CalSet II
(Candidate Device) | Elecsys ® CA 125 II CalSet
(K003969) |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | CA 125 II CalSet II is used for
calibrating the quantitative Elecsys
CA 125 II assay on the Elecsys and
cobas e immunoassay analyzers. | Same |
| Format | Lyophilized | Liquid |
| Analyte | Human CA 125 | Same |
| Matrix | Equine serum (Call) and Human
serum (Cal 2) | Same |
| Levels | Two | Same |
| Target
Ranges | Cal 1: 0 U/mL
Cal 2: 500 U/mL | Cal 1: 35 U/mL
Cal 2: 500 U/mL |
| Stability | Lyophilized:
• Up until labeled expiration date
Reconstituted:
• -20°C: 20 weeks (freeze only once)
• 2-8248C: 12 weeks
• on the Elecsys 2010 and cobas e411
(20-25°C): up to 5 hours
• on the MODULAR ANALYTICS
E170, cobas e601 and cobas e602
analyzers: use only once | Unopened:
• Store at 2-8°C until expiration date
Opened:
• at 2-8°C: 12 weeks
• on the Elecsys 2010 and cobas e411
(20-25°C): up to 5 hours
• on the MODULAR ANALYTICS
E170, cobas e601 and cobas e602
analyzers: use only once |
| Characteristic | CA 125 II CalSet II
(Candidate Device) | Elecsys® CA 125 II CalSet
(K003969) |
| Handling | Carefully dissolve the contents of
one bottle by adding exactly 1.0 mL
of distilled or deionized water and
allow to stand closed for 15 minutes
to reconstitute. Mix carefully,
avoiding foam formation.
Transfer the reconstituted calibrators
into the supplied empty labeled snap-
cap bottles.
Elecsys 2010 and cobas e 411
analyzers: The reconstituted
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 upright at
2-8°C. Due to possible evaporation
effects, not more than 5 calibration
procedures per bottle set should be
performed.
If necessary, freeze in aliquots.
MODULAR ANALYTICS, cobas e
601 and cobas e 602 analyzers:
Unless the entire volume is necessary
for calibration on the analyzers,
transfer aliquots of the reconstituted
calibrators into empty snap-cap
bottles (CalSet Vials). Attach the
supplied labels to these additional
bottles. Aliquots intended for
storage at -20°C should be frozen
immediately.
Perform only one calibration
procedure per aliquot. | The calibrators are supplied ready-
for-use in bottles compatible with the
system.
Elecsys 2010 and cobas e 411
analyzers: 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.
Due to possible evaporation effects,
not more than 5 calibration
procedures per bottle set should be
performed.
MODULAR ANALYTICS E170,
cobas e 601 and cobas e 602
analyzers: Unless the entire volume
is necessary for calibration on the
analyzers, transfer aliquots of the
ready-for-use calibrators to empty
snap-cap bottles (CalSet Vials).
Attach the supplied labels to these
additional bottles. Store the aliquots
at 2-8°C for later use.
Perform only one calibration
procedure per aliquot. |
| Characteristic | CA 125 II CalSet II
(Candidate Device) | Elecsys CA 125 II CalSet
(K003969) |
| Traceability | The Elecsys CA 125 II assay has
been standardized against the
Enzymun Test CA 125 II method.
This in turn was standardized against
the CA 125 II RIA from Fujirebio
Diagnostics. | Same |
Continued on next page
2
510(k) Summary, Continued
Table 1. Comparison of Candidate and Predicate Devices, continued
3
:
| Performance
Characteristics | The CA 125 II CalSet II was evaluated for value assignment, stability, and
reconstitution. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The data demonstrate that the performance of the CA 125 II CalSet II is
substantially equivalent to that of the predicate device, Elecsys® CA 125 II
CalSet. |
. . . . . . .
4
Image /page/4/Picture/0 description: The image shows a logo with a stylized bird design inside a circle. The bird is composed of three curved lines, suggesting movement or flight. The circle surrounding the bird contains text, though the specific words are not clear due to the image quality. The logo appears to be a symbol for an organization or company, possibly related to health or government services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 109113 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
ROCHE DIAGNOSTICS C/O DR. JANE ELLEN PHILLIPS REGULATORY PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS, IN 46250
Re: K140112
Trade/Device Name: CA 125 II CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: May 16, 2014 Received: May 19, 2014
Dear Dr. 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 commerce provide to may no may and 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 your 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 it may be subject to numbers, Title 21, Parts 800 to 898. In addition, FDA may round in the announcements concerning your device in the Federal Register.
Please be advised that FDA is 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 mat I DA has made a sold regulations administered by other Federal agencies. You must of any I cochi statutes and regenments. including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements medical device-related adverse events) (2) carren (21 CFR Part 820); and if application (201 as set form in the qualify by actions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Dr. Jane Ellen Phillips
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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.fdagov/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 -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140112
Device Name Elecsys CA 125 II CalSet II
Indications for Use (Describe) CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II assay on the Elecsys and cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth A. Stafford -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'
The burden time for this collection of information is estimated to average 79 hours per response, including the semble I he burden instructions, search existing data sources, gather and maintain the data needed and completer lifite to review instructions, search existing asia common, generaling this burden estimate or any other aspect and teller the occasion, including suggestions for reducing this burden, to:
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