(94 days)
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No
The summary describes a reagent kit for quantitative determination of electrolytes using existing laboratory systems (Beckman® CX® and CX® DELTA Systems). There is no mention of AI, ML, image processing, or any computational analysis beyond standard quantitative measurements and statistical analysis of performance data.
No
The device is an in vitro diagnostic (IVD) reagent used for the quantitative determination of various electrolytes in bodily fluids, aiding in the diagnosis and treatment of diseases related to electrolyte imbalance. It does not directly provide therapy or interact with the patient's body for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the results obtained are for the "diagnosis and treatment of" various conditions and diseases. This clearly indicates its role in the diagnostic process.
No
The device is a reagent kit (HiChem® ISE Electrolyte Reference) intended for use with specific hardware systems (Beckman® CX® and CX® DELTA Systems, SYNCHRON® CX® DELTA Systems) for the quantitative determination of analytes. It is a physical consumable, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid" and "calcium in serum, plasma and urine." These are all biological specimens.
- Purpose: The results obtained from this device are used for the "diagnosis and treatment of" various diseases and conditions involving electrolyte balance and acid-base balance. This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Professional Use: The statement "This reagent is intended for professional use only" further supports its classification as an IVD, as these devices are typically used by trained healthcare professionals in a laboratory or clinical setting.
- Performance Studies: The document describes performance studies (Precision and Patient Comparison) conducted on biological specimens (serum, plasma, CSF, urine) to demonstrate the device's analytical performance. This is a standard requirement for IVD devices.
- Predicate Device: The mention of a predicate device (SYNCHRON® CX® Systems ISE Electrolyte Reference Kit) which is also an IVD, indicates that this device is intended to perform a similar diagnostic function.
Therefore, based on the provided information, the HiChem® ISE Electrolyte Reference is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HiChem® ISE Electrolyte Reference, when used in conjunction with the HiChem® ISE Electrolyte Buffer, HiChem® CO2 Acid Reagent, HiChem® CO2 Alkaline Buffer, HiChem® Wash Concentrate, and HiChem® Calibration Standards, is intended for the quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems, HiChem® ISE Electrolyte Reference will also determine calcium in serum, plasma and urine.
Sodium results are for the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insigidus (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 antidiurelic hormone secretion, or other diseases involving electrolyte balance. Potassium results are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. Chloride results are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Carbon dioxide results are used in the diagnosis and treatment of numerous and potentially senous disorders associated with changes in the body's acid-base balance. Calcium results are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
This reagent is intended for professional use only.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ, JFL, JFP
Device Description
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Mentions image processing
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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
professional use only.
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)
Precision:
Serum and CSF controls, and urine pools were each assayed for calcium, chloride, potassium, and total CO2 twice per day in triplicate on a SYNCHRON® CX® DELTA System using both HiChem® and Beckman® flow cell reagents, wash solutions and calibrators. Data were collected on ten different days over a thirty day period. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.
Patient Comparison:
Serum, plasma, cerebrospinal fluid and urine specimens, collected from adult patients, were assayed for calcium, chloride, potassium, sodium, and total CO2 on a SYNCHRON® CX® DELTA System using HiChem® and Beckman® low cell reagents, wash solutions and calibrators. Results were compared by least squares linear regression where X = Beckman® Results and Y = HiChem® Results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision Statistics provided for Calcium, Chloride, Potassium, Sodium, and Total CO2.
Patient Comparison (Least Squares Linear Regression) results provided for Calcium (n=160 Serum/Plasma, 74 Urine), Chloride (n=160 Serum/Plasma, 78 Urine, 44 CSF), Potassium (n=160 Serum/Plasma, 80 Urine), Sodium (n=160 Serum/Plasma, 78 Urine), and Total CO2 (n=160 Serum/Plasma).
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.
SYNCHRON® CX® Systems ISE Electrolyte Reference Kit, product no. 450214
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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§ 862.1665 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
NOV 26 1999
Image /page/0/Picture/1 description: The image is a logo for "élan". The logo features a stylized letter "e" formed by several parallel lines, with a wing-like shape extending from the left side of the "e". Below the symbol is the word "élan" in a sans-serif font, with an acute accent over the "e". The logo is black and white.
élan diagnostics
Summary of 510(k) Safety and Effectiveness Information
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.
HiChem® ISE Electrolyte Reference is intended for the quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® SYNCHRON® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems, HiChem® ISE Electrolyte Reference will also determine calcium in serum, plasma and urine.
The HiChem® ISE Electrolyte Reference Kit is substantially equivalent to the SYNCHRON® CX® Systems ISE Electrolyte Reference Kit, product no. 450214, manufactured by Beckman Coulter, Inc.
The effectiveness of the ISE Electrolyte Reference Kit is shown by the following studies.
Precision
Serum and CSF controls, and urine pools were each assayed for calcium, chloride, potassium, and total CO2 twice per day in triplicate on a SYNCHRON® CX® DELTA System using both HiChem® and Beckman® flow cell reagents, wash solutions and calibrators. Data were collected on ten different days over a thirty day period. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.
Precision Statistics
| Analyte
Sample | n | HiChem® Reagents
Within Run | | | Total | | n | Beckman® Reagents
Within Run | | | Total | |
|--------------------|----|--------------------------------|-------|------|-------|------|----|---------------------------------|-------|------|-------|------|
| | | mean | 1SD | %CV | 1SD | %CV | | mean | 1SD | %CV | 1SD | %CV |
| Calcium in mg/dL | | | | | | | | | | | | |
| Serum 1 | 60 | 7.9 | 0.16 | 2.1% | 0.15 | 1.9% | 60 | 7.9 | 0.16 | 2.0% | 0.15 | 2.0% |
| Serum 2 | 60 | 11.1 | 0.09 | 0.8% | 0.11 | 1.0% | 60 | 11.2 | 0.09 | 0.8% | 0.12 | 1.1% |
| Serum 3 | 60 | 14.2 | 0.13 | 0.9% | 0.16 | 1.1% | 60 | 14.4 | 0.10 | 0.7% | 0.16 | 1.1% |
| Urine 1 | 59 | 3.4 | 0.12 | 3.5% | 0.13 | 3.9% | 60 | 3.5 | 0.12 | 3.5% | 0.14 | 4.2% |
| Urine 2 | 60 | 10.9 | 0.33 | 3.1% | 0.30 | 2.8% | 60 | 11.1 | 0.33 | 2.9% | 0.31 | 2.8% |
| Chloride in mmol/L | | | | | | | | | | | | |
| Serum 1 | 60 | 84.5 | 1.16 | 1.4% | 1.21 | 1.4% | 60 | 84.6 | 0.86 | 1.0% | 1.27 | 1.5% |
| Serum 2 | 60 | 103.2 | 0.60 | 0.6% | 1.04 | 1.0% | 60 | 103.4 | 0.74 | 0.7% | 1.01 | 1.0% |
| Serum 3 | 60 | 122.6 | 1.01 | 0.8% | 1.34 | 1.1% | 60 | 122.2 | 0.77 | 0.6% | 1.00 | 0.8% |
| Urine 1 | 59 | 64.1 | 1.16 | 1.8% | 1.21 | 1.9% | 60 | 64.1 | 1.28 | 2.0% | 1.24 | 1.9% |
| Urine 2 | 60 | 235.6 | 2.33 | 1.0% | 5.67 | 2.4% | 60 | 229.6 | 2.61 | 1.1% | 5.07 | 2.2% |
| CSF 1 | 58 | 117.5 | 1.37 | 1.2% | 1.65 | 1.4% | 59 | 117.3 | 1.57 | 1.3% | 1.73 | 1.5% |
| CSF 2 | 58 | 99.1 | 1.00 | 1.0% | 1.45 | 1.5% | 58 | 99.2 | 1.37 | 1.4% | 1.50 | 1.5% |
| Potassium in meq/L | | | | | | | | | | | | |
| Serum 1 | 60 | 2.64 | 0.021 | 0.8% | 0.034 | 1.3% | 60 | 2.59 | 0.019 | 0.8% | 0.035 | 1.4% |
| Serum 2 | 60 | 5.21 | 0.031 | 0.6% | 0.040 | 0.8% | 60 | 5.22 | 0.037 | 0.7% | 0.043 | 0.8% |
| Serum 3 | 60 | 7.88 | 0.074 | 0.9% | 0.083 | 1.1% | 60 | 7.93 | 0.057 | 0.7% | 0.065 | 0.8% |
| Urine 1 | 59 | 27.1 | 0.23 | 0.9% | 0.27 | 1.0% | 60 | 27.3 | 0.31 | 1.1% | 0.32 | 1.2% |
| Urine 2 | 60 | 123.7 | 1.67 | 1.4% | 1.67 | 1.4% | 60 | 124.5 | 2.22 | 1.8% | 2.10 | 1.7% |
1
Precision Statistics (continued)
| Analyte | Sample | HiChem® Reagents | Beckman® Reagents | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | mean | 1SD | %CV | 1SD | %CV | n | mean | 1SD | %CV | 1SD | %CV | ||
| Sodium in meq/L | Serum 1 | 60 | 114.7 | 1.71 | 1.5% | 1.51 | 1.3% | 60 | 114.9 | 1.72 | 1.5% | 1.69 | 1.5% |
| Serum 2 | 60 | 144.4 | 0.87 | 0.6% | 0.94 | 0.7% | 60 | 144.9 | 0.97 | 0.7% | 1.22 | 0.8% | |
| Serum 3 | 60 | 173.3 | 1.54 | 0.9% | 1.59 | 0.9% | 60 | 174.0 | 1.08 | 0.6% | 1.31 | 0.8% | |
| Urine 1 | 59 | 45.7 | 2.02 | 4.4% | 1.78 | 3.9% | 60 | 45.8 | 2.51 | 5.5% | 2.15 | 4.7% | |
| Urine 2 | 60 | 159.9 | 2.19 | 1.4% | 1.98 | 1.2% | 60 | 160.4 | 2.67 | 1.7% | 2.39 | 1.5% | |
| Total CO2 in mmol/L | Serum 1 | 60 | 12.6 | 0.40 | 3.2% | 0.38 | 3.0% | 60 | 12.7 | 0.38 | 3.0% | 0.36 | 2.9% |
| Serum 2 | 60 | 22.2 | 0.32 | 1.4% | 0.36 | 1.6% | 60 | 22.3 | 0.33 | 1.5% | 0.37 | 1.7% | |
| Serum 3 | 60 | 30.9 | 0.53 | 1.7% | 0.66 | 2.1% | 60 | 31.1 | 0.36 | 1.2% | 0.48 | 1.5% |
Patient Comparison
Serum, plasma, cerebrospinal fluid and urine specimens, collected from adult patients, were assayed for calcium, chloride, potassium, sodium, and total CO2 on a SYNCHRON® CX® DELTA System using HiChem® and Beckman® low cell reagents, wash solutions and calibrators. Results were compared by least squares linear regression where X = Beckman® Results and Y = HiChem® Results.
| Analyte | Specimen | Unit | n | a | b | r | range | mean X | mean Y |
|---|---|---|---|---|---|---|---|---|---|
| Calcium | Serum/Plasma | mg/dL | 160 | 0.0 | 0.989 | 0.985 | 7.1 - 10.6 | 9.26 | 9.13 |
| Urine | mg/dL | 74 | -0.2 | 1.007 | 0.998 | 2.4 - 15.2 | 8.45 | 8.3 | |
| Chloride | Serum/Plasma | mmol/L | 160 | 1.0 | 0.988 | 0.935 | 98.2 - 127.5 | 107.3 | 107.0 |
| Urine | mmol/L | 78 | -5.1 | 1.049 | 0.999 | 22.4 - 289 | 126.8 | 127.9 | |
| CSF | mmol/L | 44 | -3.4 | 1.024 | 0.985 | 113.8 - 152.4 | 126.5 | 126.1 | |
| Potassium | Serum/Plasma | meq/L | 160 | 0.13 | 0.969 | 1.000 | 3.20 - 10.82 | 5.02 | 5.00 |
| Urine | meq/L | 80 | 0.01 | 0.993 | 1.000 | 3.48 - 136.0 | 50.5 | 50.2 | |
| Sodium | Serum/Plasma | meq/L | 160 | 9.1 | 0.930 | 0.938 | 131.8 - 159.1 | 141.0 | 140.3 |
| Urine | meq/L | 78 | -0.3 | 1.000 | 1.000 | 16.9 - 288.1 | 118.2 | 117.8 | |
| Total CO2 | Serum/Plasma | mmol/L | 160 | 1.2 | 0.949 | 0.953 | 9.5 - 29.1 | 23.3 | 23.2 |
Wynn Stocking
Wynn Stocking
Manager of Regulatory Affairs Elan Diagnostics
20 August, 1999
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 26 1999
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 N. Puente Street Brea, California 92821
Re: K992842
Trade Name: HiChem® ISE Electrolyte Reference Regulatory Class: II Product Code: JGS, CEM, CGZ, JFL, JFP Dated: November 10, 1999 Received: November 12, 1999
Dear Mr. Stocking:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K992842 510(k) Number (if known):
HiChem® ISE Electrolyte Reference Device Name:
Indications For Use:
HiChem® ISE Electrolyte Reference, when used in conjunction with the HiChem® ISE Electrolyte Buffer, HiChem® CO2 Acid Reagent, HiChem® CO2 Alkaline Buffer, HiChem® Wash Concentrate, and HiChem® Calibration Standards, is intended for the quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems, HiChem® ISE Electrolyte Reference will also determine calcium in serum, plasma and urine.
Sodium results are for the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insigidus (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 antidiurelic hormone secretion, or other diseases involving electrolyte balance. Potassium results are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. Chloride results are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Carbon dioxide results are used in the diagnosis and treatment of numerous and potentially senous disorders associated with changes in the body's acid-base balance. Calcium results are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
This reagent is intended for professional use only.
Respectfully,
Wynn Stocking Requiatory Affairs Manager Elan Diagnostics
10 November, 1999
Dean Cooper
Division of Clinical Laboratory Devices
510(k) Number K992842
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)