(53 days)
Not Found
No
The summary provides no indication of AI/ML technology; it describes a calibration solution for laboratory equipment.
No
The device is used for calibration of Ion Selective Electrodes on analyzers, which are laboratory instruments, not for direct medical therapy.
No
The device is described as being for "use in the calibration of Ion Selective Electrodes," which suggests it is used to adjust or standardize other equipment, not to directly diagnose medical conditions.
No
The summary describes a device used for calibrating Ion Selective Electrodes on analyzers, which are hardware components. The predicate device is also a "Sera," indicating a physical substance used for calibration. There is no mention of the device being software-only.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use explicitly states it's for "calibration of Ion Selective Electrodes on Roche/Hitachi analyzers." Ion Selective Electrodes are used in clinical chemistry analyzers to measure the concentration of ions (like sodium, potassium, chloride) in biological samples (like blood or urine). Calibration is a crucial step in ensuring the accuracy of these measurements, which are used for diagnostic purposes.
- Predicate Device: The mention of a predicate device, "ISE Compensation Sera" (K870379), strongly suggests that this device is also intended for a similar diagnostic purpose. Compensation sera are typically used in IVD settings to adjust for matrix effects or other interferences in samples.
- Performance Studies: The mention of performance studies for "value assignment and stability" are typical evaluations conducted for IVD devices to ensure their reliability and accuracy over time.
While the "Device Description" is missing, the intended use and the context of calibration for clinical analyzers strongly point towards an IVD classification.
In summary, the primary function of calibrating equipment used to analyze biological samples for diagnostic purposes is the hallmark of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The ISE Compensator is a calibrator for Ion Selective Electrodes. Its matrix is a human serum matrix preparation with defined Sodium, Potassium and Chloride concentrations, and the active ingredients are spiked into a buffered human serum matrix. It is in liquid format and is ready to use.
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 ISE Compensator was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
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, and contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
317-521-3723 |
|--------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Corina Harper |
| Date Prepared: | August 9, 2005 |
| Device name | |
|---|---|
| Proprietary name: | ISE Compensator |
| Common name: | Calibrator |
| Classification name: | Calibrator, Multi-Analyte mixture |
| Predicate device | The ISE Compensator is substantially equivalent to the cleared ISE Compensation Sera (K870379). |
|---|---|
| ------------------ | ------------------------------------------------------------------------------------------------- |
| Intended use | ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers. |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------------------- |
Continued on next page
1
510(k) Summary, Continued
The ISE Compensator is substantially equivalent to other products in Substantial equivalence commercial distribution intended for similar use. We claim equivalency to the currently marketed ISE Compensation Sera (K870379).
The below tables compare ISE Compensator with the predicate device, ISE Substantial equivalence: Compensation Sera (K870379). Similarities
| Characteristic | Predicate Device
ISE Compensation
Sera (K870379) | ISE Compensator |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | For use in the
calibration of Sodium,
Potassium, and
Chloride on the
Boehrienger Mannheim
diagnostics/Hitachi
Systems with Ion
Selective Electrodes. | For use in the
calibration of Ion
Selective Electrodes on
Roche/Hitachi
analyzers. |
| Levels | One | Same |
| Format | Lyophilized | Liquid |
| Handling | Add 5.0 mL distilled or
deionized water. Allow
to stand for 30 minutes.
Mix carefully, avoiding
the formation of the
foam. | Ready to use. Mix well
prior to use, avoiding
the formation of the
foam. |
| Stability | Unopened:
• Store at 2-8 °C until
expiration date
Reconstituted:
• 5 days at 2-8 °C
• 5 days at -20 °C | Unopened:
• Same
After opening:
• 2 weeks at 2-8 °C |
Continued on next page
2
510(k) Summary, Continued
| Characteristic | Predicate Device
ISE Compensation
Sera (K870379) | ISE Compensator |
|----------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Matrix | Human serum matrix
with added Sodium
carbonate, Potassium
chloride,, Sodium
chloride. | Human serum matrix
preparation with
defined Sodium,
Potassium and Chloride
concentrations. |
Substantial equivalence: Similarities (continued)
The table below lists all active ingredients for ISE Compensator. Matrix The active ingredients are spiked into a buffered human serum matrix. composition
- 1
| Components | Concentration | |
|---|---|---|
| Reactive Components | Na+ | |
| K+ | ||
| Cl- | Refer to target value | |
| sheet of package insert. |
The ISE Compensator was evaluated for value assignment and stability. Performance characteristics
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.
Public Health Service
OCT 3 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416
K052193 Re:
Trade/Device Name: ISE Compensator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: September 13, 2005 Received: September 15, 2005
Dear Ms. Harper:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2 –
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: ISE Compensator
Indications For Use:
ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.
Prescription Use XXXX (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k
Roche Diagnostics Confidential