(30 days)
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No
The device description and performance studies focus on the electrochemical principles of ion-selective electrodes and standard analytical performance metrics, with no mention of AI or ML.
No
This device is an in vitro diagnostic device that measures the concentration of ions in bodily fluids for diagnosis and treatment monitoring, rather than directly applying therapy.
Yes
The intended use explicitly states the quantitative determination of sodium, potassium, and chloride and that these measurements are used in the diagnosis and treatment of various diseases.
No
The device description explicitly states it includes hardware components: "The complete measurement system for a particular ion includes the ISE, a reference electrode and electronic circuits to measure and process the EMF to give the test ion concentration."
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine. These are biological specimens.
- Diagnostic Purpose: The intended use also clearly links the measurements to the diagnosis and treatment of various diseases and conditions involving electrolyte imbalance (aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, low or high blood potassium levels, cystic fibrosis, and diabetic acidosis). This indicates a diagnostic purpose.
- Device Description: The device description explains how the device measures these analytes in the biological specimens using ion-selective electrodes.
- Performance Studies: The document includes performance characteristics like precision, linearity, and method comparison, which are typical for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (K953239; original ISE Na, K, Cl) further confirms its classification as a medical device, and specifically an IVD given the nature of the predicate.
Based on the definition of an In Vitro Diagnostic device (a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or concerning the monitoring of therapeutic measures), this device fits the criteria.
N/A
Intended Use / Indications for Use
The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes.
Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ
Device Description
An Ion-Selective Electrode (ISE) makes use of the unique properties of certain membrane materials to develop an electrical potential (electromotive force, EMF) for the measurements of ions in solution. The electrode has a selective membrane in contact with both the test solution and an internal filling solution. The internal filling solution contains the test ion at a fixed concentration. Because of the particular nature of the membrane, the test ions will closely associate with the membrane on each side. The membrane EMF is determined by the difference in concentration of the test ion in the test solution and the internal filling solution. The EMF develops according to the Nernst equation for a specific ion is solution (see package insert for further explanation).
The complete measurement system for a particular ion includes the ISE, a reference electrode and electronic circuits to measure and process the EMF to give the test ion concentration. The sodium and potassium electrodes are based on neutral carriers and the chloride electrode is based on an ion exchanger.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Between day Imprecision, Plasma
Sodium (mmol/L), n=21:
Mean: 143.0, 128.5
SD: 0.51, 0.52
CV: 0.4%, 0.4%
Potassium (mmol/L), n=21:
Mean: 6.95, 4.27
SD: 0.02, 0.01
CV: 0.3%, 0.3%
Chloride (mmol/L), n=21:
Mean: 118.8, 92.7
SD: 0.42, 0.42
CV: 0.4%, 0.5%
Between day Imprecision, Urine
Sodium (mmol/L), n=21:
Mean: 23.7, 160.5
SD: 0.77, 0.64
CV: 3.3%, 0.4%
Potassium (mmol/L), n=21:
Mean: 19.86, 59.67
SD: 0.15, 0.68
CV: 0.8%, 1.1%
Chloride (mmol/L), n=21:
Mean: 21.4, 154.5
SD: 0.51, 1.00
CV: 2.4%, 0.6%
Linearity:
Sodium:
Serum = 80-180 mmol/L
Urine = 10-250 mmol/L
Deviation +/- 5% from 40.0-250 mmol/L or +/- 3 mmol/L at concentrations 100 mg/dL increase apparent potassium levels significantly
Icterus:
No significant interference from conjugated and unconjugated bilirubin up to 60 mg/dL
Lipemia:
No significant interference up to 2000 mg/dL
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.
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K053/65
510(k) Summary – ISE Indirect Na, K, CI for Gen.2
| 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 Rd
Indianapolis IN 46250
(317) 521-3723
Contact person: Kerwin Kaufman | | |
| | Date prepared: November 11, 2005 | | |
| Device Name | Proprietary name: ISE Indirect Na, K, Cl for Gen.2 | | |
| | Common names:
Sodium Test System
Potassium Test System
Chloride Test System | | |
| | Classification names:
Ion-Specific Electrode Sodium
Ion-Specific Electrode Potassium
Ion-Specific Electrode Chloride | | |
Continued on next page
:
1
| Device
Description | An Ion-Selective Electrode (ISE) makes use of the unique properties of
certain membrane materials to develop an electrical potential (electromotive
force, EMF) for the measurements of ions in solution. The electrode has a
selective membrane in contact with both the test solution and an internal
filling solution. The internal filling solution contains the test ion at a fixed
concentration. Because of the particular nature of the membrane, the test ions
will closely associate with the membrane on each side. The membrane EMF
is determined by the difference in concentration of the test ion in the test
solution and the internal filling solution. The EMF develops according to the
Nernst equation for a specific ion is solution (see package insert for further
explanation). |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The complete measurement system for a particular ion includes the ISE, a
reference electrode and electronic circuits to measure and process the EMF to
give the test ion concentration. The sodium and potassium electrodes are
based on neutral carriers and the chloride electrode is based on an ion
exchanger. |
| Intended use /
Indications for
use | The ISE module of the Roche / Hitachi systems is intended for the
quantitative determination of sodium, potassium, and chloride in serum,
plasma, or urine using ion-selective electrodes. |
| | Sodium measurements 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.
Potassium measurements are used to monitor electrolyte balance in the
diagnosis and treatment of disease conditions characterized by low or high
blood potassium levels. Chloride measurements are used in the diagnosis and
treatment of electrolyte and metabolic disorders such as cystic fibrosis and
diabetic acidosis. |
| Predicate
Device | We claim substantial equivalence to the predicate device, original ISE Na, K,
Cl, cleared in K953239. |
| | Continued on next page |
:
2
Substantial equivalency -Similarities
The table below indicates the similarities between the modified ISE Indirect Na, K, Cl for Gen.2 device and its predicate device (original ISE Na, K, Cl, K953239).
| Feature | Predicate device: original
ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,
K, Cl for Gen.2 |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Instruments | Roche Hitachi automated analyzer
family | Same |
| Intended Use/
Indications for
Use | For the quantitative determination of
sodium, potassium, and chloride in
serum, plasma, and urine.
Sodium measurements 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.
Potassium measurements are used to
monitor electrolyte balance in the
diagnosis and treatment of disease
conditions characterized by low or
high blood potassium levels.
Chloride measurements are used in
the diagnosis and treatment of
electrolyte and metabolic disorders
such as cystic fibrosis and diabetic
acidosis. | The ISE module of the Roche / Hitachi
systems is intended for the quantitative
determination of sodium, potassium,
and chloride in serum, plasma, or
urine using ion-selective electrodes.
Sodium measurements 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. Potassium measurements
are used to monitor electrolyte balance
in the diagnosis and treatment of
disease conditions characterized by
low or high blood potassium levels.
Chloride measurements are used in the
diagnosis and treatment of electrolyte
and metabolic disorders such as cystic
fibrosis and diabetic acidosis. |
| Feature | Predicate device: original
ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,
K, Cl for Gen.2 |
| Test principle | | |
| Sample types | Serum, Plasma (Lithium heparin) or
Urine | Same |
| Determination of
Sodium,
Potassium and
Chloride | An Ion-Selective Electrode (ISE)
makes use of the unique properties
of certain membrane materials to
develop an electrical potential
(electromotive force, EMF) for the
measurements of ions in solution.
The electrode has a selective
membrane in contact with both the
test solution and an internal filling
solution. The internal filling
solution contains the test ion at a
fixed concentration. Because of the
particular nature of the membrane,
the test ions will closely associate
with the membrane on each side.
The membrane EMF is determined
by the difference in concentration of
the test ion in the test solution and
the internal filling solution. The
EMF develops according to the
Nernst equation for a specific ion is
solution (see package insert for
further explanation).
The complete measurement system
for a particular ion includes the ISE,
a reference electrode and electronic
circuits to measure and process the
EMF to give the test ion
concentration. The sodium and
potassium electrodes are based on
neutral carriers and the chloride
electrode is based on an ion
exchanger. | Same |
| Feature | Predicate device: original
ISE Na, K, Cl (K953239) | Modified device: ISE Indirect Na,
K, Cl for Gen.2 |
| Electrode / Reagent information | | |
| Ion-Specific
Electrodes | Sodium Electrode/ Cartridge
Potassium Electrode/ Cartridge
Chloride Electrode/ Cartridge
Reference Electrode/ Cartridge | Same |
| Electrode
Onboard
Stability | Sodium, Potassium and Chloride
Electrodes, 2 months or 9000 tests
Reference Electrode, at least 6
months | Same |
| Calibrators S1,
S2 for two-point
calibration | S1: ISE Standard Low
S2: ISE Standard High | Same |
| Auxiliary
Reagents | ISE 1 N potassium chloride
(Reference Electrolyte) | Same |
| Performance characteristics | | |
| Reportable
Range | Serum/Plasma:
$Na^+: 80 - 180 mmol/L$
$K^+: 1.5 - 10 mmol/L$
$Cl^-: 60-140 mmol/L$
Urine:
$Na^+: 10 - 250 mmol/L$
$K^+: 1 - 100 mmol/L$
$Cl^-: 20 - 250 mmol/L$ | Serum/Plasma:
$Na^+$ : Same
$K^+$ : Same
$Cl^-$ : Same
Urine:
$Na^+$ : Same
$K^+$ : Same
$Cl^-$ : 10 - 250 mmol/L |
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The table below indicates the differences between the modified ISE Indirect Substantial Na, K, Cl for Gen.2 device and its predicate device (original ISE Na, K, Cl, equivalency -Differences K953239). and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
| Feature | Predicate device: original
ISE Na, K, Cl (K953239)
Electrode / Reagent information | Modified device: ISE Indirect Na,
K, Cl for Gen.2 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISE Diluent
Composition | 650 mmol/L Boric acid
Preservative (Gentamicin based) | 10 mmol/L HEPES buffer
7 mmol/L Triethanolamine
Preservative |
| ISE Internal
Standard
Composition | 650 mmol/L Boric acid
32.3 mmol/L Sodium Chloride
12.9 mmol/L Sodium bicarbonate
1.6 mmol/L Potassium phosphate
Preservative (Gentamicin based) | 10 mmol/L HEPES buffer
7 mmol/L Triethanolamine
3.06 mmol/L Sodium chloride
1.45 mmol/L Sodium acetate
0.16 mmol/L Potassium chloride
Preservative |
| Electrode Slope
Ranges | Sodium: 32.0 to 68.0 mV/decade
Potassium: 32.0 to 68.0 mV/decade
Chloride: -35.0 to -68.0 mV/decade | Sodium: 50 to 68 mV/decade
Potassium: 50 to 68 mV/decade
Chloride: -40 to -68 mV/decade |
| Calibrator, S3
for compensation | Precical Calibrator Serum | ISE Compensator (serum based) |
| Quality control | Precitrol-N Control Serum and
Precitrol-A Control Serum or other
commercially available controls | Precinorm U and Precipath U or
other commercially available
controls |
| ISE Cleaning
Solution | 4 N NaOH/System Cleaning
Solution | ISE Cleaning Solution:
Sodium hydroxide, 12% with
Sodium hypochlorite solution 100 mg/dL
increase apparent potassium levels
significantly
Icterus:
No significant interference from
conjugated and unconjugated bilirubin
up to 60 mg/dL
Lipemia:
No significant interference up to 2000 mg/dL |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 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 in flight, composed of three curved lines that suggest wings and a body. The bird is oriented towards the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 4 2005
Mr. Kerwin Kaufman, MBA, MT (ASCP) Regulatory Affairs Consultant Centralized Diagnostics Roche Diagnostics 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250
K053165 Re:
K055105
Trade/Device Name: ISE Indirect Na, K, CI for Gen.2 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ Dated: November 11, 2005 Received: November 14, 2005
Dear Mr. Kaufman:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section - 10(tr) premainer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosme) to regally mancessa provice Americal Device Americans, or to commerce pror to May 20, 1970, the chaemient auto crowisions of the Federal Food, Drug, devices that have been reclassified in accordance who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premissions of the Act and Cosment Act (Act) that to not require approvine of the general controls provisions of the Act. The Act. The You may, therefore, market the devreet, basjocrequirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (See above) into . Existing major regulations affecting your device it may be subject its such additional comicr. Parts 800 to 895. In additions (CFR), Parts 800 to 895 Can oc louid in This 21, Courselects concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a backers with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a decemmanon mac Jour ac-rooms of each agencies. You must or any Federal statutes and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, intrans, intrans 800); and good manufacturing practice CFK Part 807), laoching (21 OF N F its systems (QS) regulation (21 CFR Part 820).
10
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin maneting your article equivalence of your device to a legally prematic notification: "The PDF interestion 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, IT you teche specific information and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v lure Diagnostic DoMo Broading by reference to premarket notification" (21CFR Part 807.97). I cludion chittled, "Milonanaing of responsibilities under the Act from the r ou may other general miermational 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 vours,
Alberto G.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known):
Device Name: ISE Indirect Na, K, Cl for Gen.2
Indications For Use:
The ISE module of the Roche / Hitachi systems is intended for the quantitative electrodes The ISH module of the Koche / Hitachi byticine is not and ing ion-selective electrodes.
Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive
in the survey and the states and the stakes is avaration of large amount Sodium measurements are used in the diagnosis and a chronic excetion of large amounts of secretion of the normolie aldosterone), diabeted institution is disease (caused by dilute urne, accompanied by extreme mirst), actival includes and intentionals are used to monitor other diseases involving electrolyte imbalance. Potassium measurements are used to monitor other diseases involving electionyle infounditions characterized by low of
electrolyte balance in the diagnosis and treatment of disements and treatment of electrolyte balance in the dragnosis and neasurements are used in the diagnosis and treatment of
high blood potassium levels. Chloride measurement diskations asidenis high blood polassium revels. Onlorido has cystic fibrosis and diabetic acidosis.
electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Page 1 of
Confidential
Office and gritter Diagnostic perfore twon. allon and Safety
053/6.5
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