HICHEM ISE ELECTROLYTE BUFFER

K992844 · Elan Holdings, Inc. · JGS · Nov 26, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992844
• Device Name: HICHEM ISE ELECTROLYTE BUFFER
• Applicant: Elan Holdings, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended 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.

Device Story

HiChem® ISE Electrolyte Buffer is an in vitro diagnostic reagent kit used with Beckman® SYNCHRON® CX® and CX® DELTA clinical chemistry systems. The device functions as a buffer solution within the system's ion-selective electrode (ISE) flow cell assembly. It facilitates the quantitative measurement of sodium, potassium, chloride, total CO2, and calcium in clinical specimens (serum, plasma, urine, CSF). The system processes samples automatically; the buffer maintains the electrochemical environment necessary for the ISE sensors to generate signals proportional to analyte concentration. Healthcare professionals (laboratory technicians/pathologists) use the resulting quantitative data to diagnose and monitor metabolic and electrolyte disorders. The device is intended for clinical laboratory settings.

Clinical Evidence

Bench testing only. Precision studies (n=58-60 per sample) evaluated within-run and total imprecision for all analytes across serum, urine, and CSF matrices over 30 days. Patient comparison studies (n=44-160 per analyte) compared HiChem® reagents against Beckman® reagents using least squares linear regression, showing high correlation (r=0.935 to 1.000) across clinical ranges.

Technological Characteristics

In vitro diagnostic reagent buffer for ion-selective electrode (ISE) analysis. Designed for use on Beckman® SYNCHRON® CX®/CX® DELTA systems. Operates via electrochemical sensing in a flow cell. No specific materials of construction or software algorithms described; device is a chemical reagent kit.

Indications for Use

Indicated for quantitative determination of sodium, potassium, chloride, total CO2, and calcium in serum, plasma, urine, and CSF to aid in diagnosis and treatment of electrolyte/metabolic disorders, including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, cystic fibrosis, diabetic acidosis, acid-base balance disorders, parathyroid disease, and chronic renal disease. For professional use only.

Regulatory Classification

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.

Predicate Devices

• SYNCHRON® CX® Systems ISE Electrolyte Buffer Kit (product no. 472095)

Submission Summary (Full Text)

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V 26 1999

élan diagnostics

K992844

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% |

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## 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

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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)