HICHEM ISE ELECTROLYTE REFERENCE

K992842 · Elan Holdings, Inc. · JGS · Nov 26, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992842
• Device Name: HICHEM ISE ELECTROLYTE REFERENCE
• 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 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.

Device Story

HiChem® ISE Electrolyte Reference is an in vitro diagnostic reagent kit used with Beckman® SYNCHRON® CX® and CX® DELTA clinical chemistry systems. The device functions as a reference solution for ion-selective electrode (ISE) analysis of electrolytes (sodium, chloride, potassium, calcium, total CO2) in clinical specimens (serum, plasma, urine, CSF). Operated by laboratory professionals in clinical settings, the reagents facilitate the automated measurement of electrolyte concentrations. The system transforms electrochemical signals from the ISE flow cell into quantitative concentration values. These results are displayed to clinicians to aid in the diagnosis and management of metabolic, renal, and endocrine disorders, including cystic fibrosis, diabetes insipidus, and acid-base imbalances. The device provides a diagnostic alternative to existing manufacturer-specific reagents for the specified Beckman platforms.

Clinical Evidence

Bench testing only. Precision studies (n=60 per sample) evaluated within-run and total imprecision for calcium, chloride, potassium, sodium, and total CO2 across serum, urine, and CSF matrices. Patient comparison studies (n=44 to 160 per analyte) compared HiChem® reagents against Beckman® reagents using least squares linear regression. Correlation coefficients (r) ranged from 0.935 to 1.000, demonstrating high agreement between the subject and predicate reagents.

Technological Characteristics

In vitro diagnostic reagent kit for ISE analysis. Components include reference solutions, buffers, acid reagents, and wash concentrates. Operates via ion-selective electrode potentiometry on Beckman® SYNCHRON® CX®/CX® DELTA systems. Designed for professional laboratory use; requires specific instrument configuration for calcium determination. No specific material standards or software architecture details provided.

Indications for Use

Indicated for adult patients requiring quantitative determination of sodium, chloride, total CO2, potassium, and calcium in serum, plasma, urine, or cerebrospinal fluid to diagnose and monitor electrolyte imbalances, metabolic disorders, acid-base balance, and parathyroid or renal diseases.

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 Reference Kit (product no. 450214)

Submission Summary (Full Text)

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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<br>Sample | n | HiChem® Reagents<br>Within Run | | | Total | | n | Beckman® Reagents<br>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% |

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K992842

## 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

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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 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 [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 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

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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

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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)