(94 days)
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No
The summary describes a chemical reagent kit for use with existing laboratory analyzers and does not mention any computational or algorithmic components, let alone AI/ML.
No.
Explanation: This device is a reagent buffer intended for in vitro diagnostic testing to quantitatively determine various electrolytes and compounds in biological fluids. It is used to aid in the diagnosis and treatment of conditions, but it does not directly treat or prevent a disease in a living body, which is characteristic of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the results obtained are "for the diagnosis and treatment of" various diseases and conditions, which is a clear indicator of a diagnostic device.
No
The device is a reagent (chemical substance) intended for use with specific hardware systems (Beckman® CX® and CX® DELTA Systems) to perform quantitative determinations. It is not a software-only device.
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 product 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..." and "calcium in serum, plasma and urine." These are all biological specimens taken in vitro (outside the body).
- Diagnostic Purpose: The "Intended Use / Indications for Use" section also clearly links the results of these determinations to the "diagnosis and treatment" of various diseases and conditions (e.g., aldosteronism, diabetes insipidus, electrolyte imbalance, cystic fibrosis, diabetic acidosis, acid-base balance disorders, parathyroid diseases, chronic renal disease, tetany). This indicates the results are used for diagnostic purposes.
- Professional Use: The statement "This reagent is intended for professional use only" further supports its use in a clinical or laboratory setting for diagnostic testing.
Therefore, based on the intended use for quantitative determination of analytes in biological specimens for diagnostic purposes, this device fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
HiChem® ISE Electrolyte Buffer, when used in conjunction with the HiChem® ISE Electrolyte Reference, 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 Buffer 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 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 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).
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGE, 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
This reagent is intended for 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, chioride, potassium, sodium, 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 palients, were assayed for calcium, chloride, potassium, sodium, and total CO2 on a SYNCHRON® CX® DELTA System using HiChem® and Beckman® flow 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.)
Key metrics for the performance studies are provided in the tables under "Precision" and "Patient Comparison". These include:
- Precision: Within Run 1SD, Within Run %CV, Total 1SD, Total %CV for various analytes (Calcium, Chloride, Potassium, Sodium, Total CO2) in different sample types (Serum, Urine, CSF).
- Patient Comparison (Linear Regression): a (intercept), b (slope), r (correlation coefficient), range, mean X (Beckman® Results), mean Y (HiChem® Results) for various analytes in different specimen types (Serum/Plasma, Urine, CSF).
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.
The HiChem® ISE Electrolyte Buffer Kit is substantially equivalent to the SYNCHRON® CX® Systems ISE Electrolyte Buffer Kit, product no. 472095, manufactured by Beckman Coulter, Inc.
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
V 26 1999
élan diagnostics
Summary of 510(k) Safetv 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 Buffer is intended for the quantitative determination of sodium, potassium, chloride, and total CC2 in serum and plasma, and sodium, potassium 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 Buffer will also determine calcium in serum, plasma and urine.
The HiChem® ISE Electrolyte Buffer Kit is substantially equivalent to the SYNCHRON® CX® Systems ISE Electrolyte Buffer Kit, product no. 472095, manufactured by Beckman Coulter, Inc.
The effectiveness of the ISE Electrolyte Buffer Kit is shown by the following studies.
Precision
Serum and CSF controls, and urine pools were each assayed for calcium, chioride, potassium, sodium, 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
| HiChem® Reagents | Beckman® Reagents | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | Within Run | Total | Within Run | Total | ||||||||
| Sample | n | mean | 1SD | %CV | 1SD | %CV | n | 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)
| HiChem® Reagents | Beckman® Reagents | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | Sample | n | Within Run | Total | n | Within Run | Total | |||||||
| mean | 1SD | %CV | 1SD | %CV | 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% | 59 | 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 palients, were assayed for calcium, chloride, potassium, sodium, and total CO2 on a SYNCHRON® CX® DELTA System using HiChem® and Beckman® flow 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing ribbons.
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: K992844
Trade Name: HiChem® ISE Electrolyte Buffer Regulatory Class: II Product Code: JGS, CEM, CGE, 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 Putman
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
510(k) Number (if known): K992844
Device Name:
HiChem® ISE Electrolyte Buffer
Indications For Use:
HiChem® ISE Electrolyte Buffer, when used in conjunction with the HiChem® ISE Electrolyte Reference, 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 Buffer 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 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 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 Regulatory Affairs Manager Elan Diagnostics
10 November, 1999
Jean Coopr
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K992844
(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) ✓
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)