(112 days)
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No
The document describes a chemical calibrator for a clinical chemistry system and does not mention any AI or ML components or functionalities.
No.
The device is described as an "in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (EC02) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system," which means it is used to calibrate other diagnostic devices, not to directly treat or diagnose a medical condition.
No
The device is a calibrator, used to calibrate diagnostic devices, but it is not a diagnostic device itself.
No
The device is a liquid calibrator, which is a physical substance used for calibration, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the CHEM III CAL is an "in vitro diagnostic product".
- Function: The device is used for the calibration of assays (tests) performed on a clinical chemistry system. Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: The description details the composition and packaging of the calibrator, which is a reagent used in the diagnostic process.
N/A
Intended Use / Indications for Use
The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Chemistry III Calibrator (CHEM III CAL) is a three level, liquid calibrator. It is packaged as a kit of six vials, two vials each of Levels 1, 2 and 3 with 2.5 mL per vial. CHEM III CAL is a multianalyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.
Mentions image processing
Not Found
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)
Calibrator
- For opened products, once the cap is removed, assigned values are stable for 7 days . stored on the Dimension® clinical chemistry system.
- . Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C.
The shelf life of the Dimension® CHEM III CAL is 12 months.
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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§ 862.1150 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.
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(123321
510k Summary
FEB 1 5 2013
Dimension® Chemistry III Calibrator (CHEM III CAL)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. 510(k) Number
-
- Applicant: Rose T. Marinelli Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark, DE 19714-6101. Office Number: 302-631-8805; Fax Number: 302-631-6299
- Date: October 25, 2012
4. Proprietary and Established Names:
Dimension® Chemistry III Calibrator (CHEM III CAL)
5. Requlatory Information:
Chemistry III Calibrator (CHEM III CAL)
Requlation section: 21 CFR 862.1150 Calibrator, Multi-Analyte Classification: Class II Product Code: JIX. Panel: Clinical Chemistry
6. Predicate Devices:
The predicate device used to demonstrate substantial equivalence to the Dimension® Chemistry III Calibrator (CHEM III CAL) is the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) previously cleared under K062334.
7. Device Description:
The Chemistry III Calibrator (CHEM III CAL) is a three level, liquid calibrator. It is packaged as a kit of six vials, two vials each of Levels 1, 2 and 3 with 2.5 mL per vial. CHEM III CAL is a multianalyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.
8. Intended Use:
The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry svstem.
1
9. Indication(s) for Use:
The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.
10. Substantial Equivalence Information:
Similarities for Dimension® CHEM III CAL
| Feature | New Device: Dimension®
Chemistry III Calibrator (CHEM III
CAL) (DC130) | Predicate: Dimension Vista®
Chem 3 Calibrator (CHEM 3
CAL) (KC130) K062334 |
|--------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Preparation | Liquid:
Provided ready to use. | Liquid:
Provided ready to use. |
| Storage | 2 – 8 °C | 2 - 8 °C |
| Matrix | Aqueous product containing ethyl
alcohol, ammonium bicarbonate
and sodium carbonate. | Aqueous product containing
ethyl alcohol, ammonium
bicarbonate and sodium
carbonate. |
| Traceability | AMM - ASC Grade Ammonium
Sulfate
EC02 -- NIST SRM 351
ETOH - USP Grade Ethyl Alcohol | AMM - ASC Grade Ammonium
Sulfate
EC02 - NIST SRM 351
ETOH - USP Grade Ethyl
Alcohol |
Differences for Dimension® CHEM III CAL
| Feature | New Device: Dimension®
Chemistry III Calibrator (CHEM
3 CAL) (DC130) | Predicate: Dimension Vista®
Chem 3 Calibrator (CHEM 3 CAL)
(KC130) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CHEM III CAL is an in vitro
diagnostic product for the
calibration of Ammonia (AMM),
Carbon Dioxide (EC02) and
Ethyl Alcohol (ETOH) assays on
the Dimension® clinical
chemistry system. | The CHEM 3 CAL is an in vitro
diagnostic product for the calibration.
of Ammonia (AMON), Carbon
Dioxide (C02) and Ethyl Alcohol
(ETOH) methods on the Dimension
Vista® System. |
| Units | µg/dL and µmol/L | µmol/L |
| Calibrator
Levels | 3 levels | 2 levels |
| Calibrator
Levels for
AMM only | Calibrator Level 3 – 1405 µg/dL
[825 µmol/L] | Calibrator Level 3 – 1050 µmol/L |
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11. Standard/Guidance Document Reference:
- · CLSI, EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009.
12. Performance Characteristics
Calibrator
- For opened products, once the cap is removed, assigned values are stable for 7 days . stored on the Dimension® clinical chemistry system.
- . Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C.
The shelf life of the Dimension® CHEM III CAL is 12 months.
- Conclusion: The Dimension® Chemistry III Calibrator (CHEM III CAL) is substantially equivalent in principle and performance to the Dimension Vista® Chemistry 3 Calibrator.
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Image /page/3/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15.2013
Siemens Healthcare Diagnostics, Inc. c/o Rose T. Marinelli 500 GBC Drive P.O. Box 6101/MS 514 Newark, DE 19714-6101
Re: K123321
Trade/Device Name: Dimension Chemistry III Calibrator (CHEM III CAL) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX Dated: February 01, 2013 Received: February 07, 2013
Dear Ms. Marinelli:
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 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 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 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.
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Page 2—Ms. Marinelli
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123321
Device Name: Dimension® Chemistry III Calibrator (CHEM III CAL)
Indications for Use:
The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (C02) and Ethyl Alcohol (ETOH) methods on the Dimension® clinical chemistry system.
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 Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.02.15 10:17:42 -05'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K123321 510(k)