(76 days)
Not Found
No
The device description details a chemical assay using ion-selective electrodes and a microprocessor to calculate results based on stored calibration parameters. There is no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as "For in vitro diagnostic use only" and measures sodium concentration in serum and plasma, which is used in the diagnosis and treatment of various conditions. It does not exert a therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance." This directly indicates its role in diagnosis.
No
The device description clearly details physical components like slides, electrodes, and calibrator kits, and describes a chemical reaction and potentiometric measurement process, indicating it is a hardware-based in vitro diagnostic device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only."
- Measurement of Analytes in Biological Samples: The device measures sodium concentration in serum and plasma, which are biological samples.
- Purpose of Measurement: The measurements are used in the "diagnosis and treatment" of various diseases involving electrolyte imbalance. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details how the device interacts with the sample (serum and plasma) to perform the measurement using chemical and electrochemical principles, which is characteristic of IVD devices.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Na DT Slides quantitatively measure sodium (Na ) concentration in serum and plasma. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance.
VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JGS, JIX
Device Description
The VITROS Chemistry Products Nat DT Slide assay is performed using the VITROS Chemistry Products Na DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS Na " DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of sodium ions. All reactions necessary for a single quantitative measurement of sodium take place within the multi-layered analytical element of a VITROS Chemistry Products Na DT Slide. The slide consists of two ion-selective electrodes, each containing methyl monensin (an ionophore for sodium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.
VITROS Chemistry Products Na DT Slides use ion-selective electrodes for potentiometric measurements of ionic sodium. Ionic sodium determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products Na DT Slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode. which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge. The sodium ions in the tested reference and sample fluids migrate to the silver silver silver chloride lavers and establishes equilibrium.
After an incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of sodium ions in the respective fluids to produce a potential for the concentration cell. The VITROS DT60/DT6011 Chemistry System's microprocessor uses this measurement and the stored calibration parameters to determine the concentration value of the sodium ion in the sample fluid. The test result is reported in millimoles per liter (mmol/ L).
VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.
The VITROS DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Mentions image processing
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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
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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 information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products Na DT Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured sodium values spanning the assay range.
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
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
Summary Information
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K09186
-
Submitter Ortho-Clinical Diagnostics, Inc. 1. name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 (585) 453-4041 contact email: mhanna1(@its.jnj.com
Contact Person: Marlene A. Hanna -
- Date Special 510(k) prepared: June 18, 2009 Preparation date
-
Trade or Proprietary Name: Device 3. VITROS Chemistry Products Na+ DT Slides name Common Name: sodium test Classification Name: sodium test system (21 CFR 862.1665)
VITROS Chemistry Products DT Calibrator Kit Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)
- The VITROS Chemistry Products Nat DT Slides (modified) and VITROS Chemistry 4. Predicate Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry device Products Na Slides (K081411, cleared on June 30, 2008) and VITROS Chemistry Products DT Calibrator Kit (K083680, cleared February 26, 2009).
Continued on next page
1
510(k) Summary, Continued
- Device Description The VITROS Chemistry Products Nat DT Slide assay is performed using the VITROS Chemistry Products Na DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS Na " DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of sodium ions. All reactions necessary for a single quantitative measurement of sodium take place within the multi-layered analytical element of a VITROS Chemistry Products Na DT Slide. The slide consists of two ion-selective electrodes, each containing methyl monensin (an ionophore for sodium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.
VITROS Chemistry Products Na DT Slides use ion-selective electrodes for potentiometric measurements of ionic sodium. Ionic sodium determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products Na DT Slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode. which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge. The sodium ions in the tested reference and sample fluids migrate to the silver silver silver chloride lavers and establishes equilibrium.
After an incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of sodium ions in the respective fluids to produce a potential for the concentration cell. The VITROS DT60/DT6011 Chemistry System's microprocessor uses this measurement and the stored calibration parameters to determine the concentration value of the sodium ion in the sample fluid. The test result is reported in millimoles per liter (mmol/ L).
VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.
The VITROS DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
2
- Device intended use
VITROS Chemistry Products Na DT Slides
For in vitro diagnostic use only. VITROS Nat DT Slides quantitatively measure sodium (Na ) concentration in serum and plasma.
VITROS Chemistry Products DT Calibrator Kit
For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
Continued on next page
3
510(k) Summary, Continued
The VITROS Chemistry Products Na DT Slide (modified) and VITROS Chemistry 7. Comparison to predicate Products DT Calibrator Kit are substantially equivalent to VITROS Chemistry Products Na Slide and VITROS Chemistry Products DT Calibrator Kit, which were device · Cleared by the FDA for in vitro diagnostic use.
VITROS Chemistry Products Na Slide: (K081411, cleared June 30, 2008) VITROS Chemistry Products DT Calibrator Kit: (K083680, cleared February 26, 2009).
Table 1 lists the characteristics of the tests performed using the VITROS Na* DT Slide (modified) and the VITROS Na DT Slide (current).
Table 1. List of VITROS Chemistry Products Na DT Slide Characteristics: Comparison to Predicate Device
| Device
Characteristic | New Device
VITROS Chemistry Products Na+ DT Slide
(Modified) | Predicate Device
VITROS Chemistry Products Na+ Slide
(Current) |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change. | For in vitro diagnostic use only.
VITROS Na+ DT Slides quantitatively measure
sodium (Na+) concentration in serum and
plasma. |
| Fundamental
scientific technology | No Change. | Dry, multilayered slide utilizing direct
potentiometry |
| Reactive Ingredients
per cm2 | No Change. | Silver 0.4 mg; silver chloride 0.2 mg; sodium
chloride 0.3 mg; and methyl monensin 50 ug. |
| Sample type | No Change. | Serum, plasma |
| Instrumentation | VITROS 250/350/950 and 5,1 FS Chemistry
Systems and the VITROS 5600 Integrated System | VITROS DT60 and DT60II Chemistry Systems |
| Manufacturing
Process of the ISE
baseweb* (Ag/AgCl
and Support Layers
of the Na+ DT Slide) | Same | Magnetic sputter deposition |
| Composition of ISE
baseweb component | Same | Ag/AgCl concentration: Silver 0.4 mg and
silver chloride 0.2 mg
Nickel Stripes: NiCr (80% Nickel, 20%
Chromium). |
*ISE (Ion-Selective Electrode) baseweb= Polyethylene terephthalate film (substrate used for metallized film) coated with silver (Ag)/ silver chloride (Ag/Cl) and striped with nominal nickel (Ni) stripes. The "ISE baseweb" refers to the Ag/ AgCl with nickel stripes layer and support layer of the VITROS Chemistry Products Na+ DT Slide.
NOTE: No modifications were made to VITROS Chemistry Products DT Calibrator Kit.
Continued on next page
4
510(k) Summary, Continued
8. Conclusions
The information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products Na DT Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured sodium values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products Na DT Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlene Hanna, RAC 100 Indigo Drive, Rochester, NY 14626-5101
SEP - 3 2009
: ::
、
Re: K091861 Trade/Device Name: VITROS Chemistry Products Na+ DT Slides Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, JIX Dated: June 18, 2009 Received: June 19, 2009
Dear Ms. Hanna:
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).
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.
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part . 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indication for Use
510(k) Number (if known):
- Device Name: VITROS Chemistry Products Na DT Slides
Indication For Use: For in vitro diagnostic use only. VITROS Na DT Slides quantitatively measure sodium (Na ) concentration in serum and plasma. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance.
- Device Name: VITROS Chemistry Products DT Calibrator Kit
VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic 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 (OV/D)
A
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091861
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