GenChem ISE Electrolyte Buffer, when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem CO2 Acid Reagent, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards, is intended for the quantitative determination of sodium, potassium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and 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 insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by the destruction of the adrenal glands), dehvdration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. 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 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 serious 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 spasm).

Device Description

Sodium, Potassium, Chloride, CO2 and Calcium are determined by the use of Ion Specific Electrodes, the conductivity of which is proportional to the concentration of electrolyte in the sample which is mixed with high ionic strength buffer using the ISE Solution as the reference.

AI/ML Overview

This document describes the performance characteristics and acceptance criteria for the GenChem ISE Electrolyte Buffer, a device used for the quantitative determination of various electrolytes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through its performance in precision, linearity, sensitivity, and patient comparison studies. The performance is compared to established methods using a predicate device (Beckman CX3 Synchron Analyzer). Given that this is a 510(k) summary for a reagent/buffer, the "acceptance criteria" are implied by the demonstration of performance that is substantially equivalent to a legally marketed predicate device. The values provided represent the device's reported performance which met the implicit acceptance for commercialization.

Performance Metric	Analyte	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Precision	All Electrolytes	(Within-Day & Day-to-Day) – CV values and standard deviations should be comparable to the predicate device and within clinically acceptable limits for the respective analytes. (Specific numerical criteria are not explicitly stated as "acceptance criteria" but rather as results of testing for substantial equivalence).	Within-Day (N=60): Details are presented in a highly fragmented table. The text next to the tables appears to be OCR errors and garbled. However, the tables themselves, while presented poorly, likely contain the standard deviation (SD) and Coefficient of Variation (CV) for S-1, S-2, S-3 (presumably control levels), U-1, U-2. Day-to-Day (N=60): Similarly, data for S-1, S-2, U-1, U-2, S-3 are presented, presumably showing SD/CV. The data is unreadable in the provided text, but the study was conducted.
Linearity/Reportable Range	Calcium	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0.8 – 14.3 mg/dL. Intercept: 0.34, Slope: 0.911, R2: 1.000, Sey: 0.35.
	Sodium	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0 – 200 mmol/L. Intercept: 2.37, Slope: 0.968, R2: 1.000, Sey: 2.61.
	Potassium	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0.9 – 15.2 mmol/L. Intercept: -0.09, Slope: 1.017, R2: 1.000, Sey: 0.03.
	Chloride	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0 – 197 mmol/L. Intercept: -0.71, Slope: 0.999, R2: 1.000, Sey: 0.99.
	CO2	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0 – 40 mmol/L. Intercept: 0.15, Slope: 1.000, R2: 1.000, Sey: 0.41.
Sensitivity	Calcium	Limit of detection should be clinically acceptable.	Limit of Detection: 1.5 mg/dL.
	Sodium	Limit of detection should be clinically acceptable.	Limit of Detection: 10 mmol/L.
	Potassium	Limit of detection should be clinically acceptable.	Limit of Detection: 1.0 mmol/L.
	Chloride	Limit of detection should be clinically acceptable.	Limit of Detection: 15 mmol/L.
	Total CO2	Limit of detection should be clinically acceptable.	Limit of Detection: 5.0 mmol/L.
Patient Comparison	All Electrolytes	Comparison results (slope (m), intercept (b), correlation coefficient (r)) should demonstrate substantial equivalence to the predicate device. An 'r' value close to 1 indicates good correlation.	Calcium (Serum): n=80, m=0.989, b=0.0, r=0.985, Range=7.1-10.6.Calcium (Plasma): n=80, m=0.990, b=0.0, r=0.995, Range=7.1-10.7.Calcium (Urine): n=74, m=1.007, b=-0.2, r=0.998, Range=2.4-15.2. Chloride (Serum): n=80, m=0.988, b=1.0, r=0.935, Range=98-127. Chloride (Plasma): n=80, m=0.998, b=0.8, r=0.985, Range=98-127.Chloride (Urine): n=78, m=1.049, b=-5.1, r=0.999, Range=22-289. Chloride (CSF): n=44, m=1.024, b=-3.4, r=0.985, Range=113-152.Potassium (Serum): n=80, m=0.969, b=0.13, r=1.000, Range=3.2-10.8.Potassium (Plasma): n=80, m=0.987, b=0.15, r=1.000, Range=3.2-10.8. Potassium (Urine): n=80, m=0.993, b=0.01, r=1.000, Range=3.5-136. Sodium (Serum): n=80, m=0.930, b=9.1, r=0.938, Range=132-159.Sodium (Urine): n=78, m=1.000, b=-0.3, r=1.000, Range=17-288. Total CO2 (Serum): n=80, m=0.949, b=1.2, r=0.953, Range=9.5-29.Total CO2 (Plasma): n=80, m=0.965, b=0.9, r=0.960, Range=9.5-29.

2. Sample Size Used for the Test Set and Data Provenance

Precision (Test Set):
- Within-Day: N=60 for each analyte, across different control levels (S-1, S-2, S-3, U-1, U-2).
- Day-to-Day: N=60 measurements over 30 days for each analyte, across different control levels (S-1, S-2, U-1, U-2, S-3).
- Data Provenance: Not explicitly stated, but typically these types of studies use manufactured controls and spiked samples, likely performed within the manufacturer's laboratory or a designated testing facility. The document mentions "commercially available linearity standards" and "serum control."
Linearity (Test Set): Commercially available linearity standards were analyzed in triplicate. The exact number of distinct linearity standards (concentration points) is not specified, but typically involves at least 5-7 levels.
Sensitivity (Test Set): A serum control was repetitively assayed, and then diluted, with replicates of 10 runs to establish the limit of detection. The sample size for establishing the limit of detection for each analyte was 10 replicates.
Patient Comparison (Test Set):
- Serum, plasma, cerebrospinal fluid (CSF), and urine specimens were used.
- Calcium (Serum, Plasma): n=80 each.
- Calcium (Urine): n=74.
- Chloride (Serum, Plasma): n=80 each.
- Chloride (Urine): n=78.
- Chloride (CSF): n=44.
- Potassium (Serum, Plasma, Urine): n=80 each.
- Sodium (Serum): n=80.
- Sodium (Urine): n=78.
- Total CO2 (Serum, Plasma): n=80 each.
- Data Provenance: Collected from adult patients. No specific country of origin is mentioned, but typically this refers to a clinical site within the USA for FDA submissions. The study is prospective in the sense that these samples were collected and analyzed specifically for this comparison study, in parallel on both the predicate and test devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (electrolyte buffer for a clinical chemistry analyzer) does not typically involve human expert interpretation for "ground truth" establishment in the way that image analysis or diagnostic AI systems do. The "ground truth" for the test set is established by:

Reference Methods/Predicate Device: For the patient comparison study, the "ground truth" is the result obtained from the legally marketed predicate device (Beckman CX3 Synchron Analyzer), which is an established and accepted methodology for measuring these electrolytes.
Known Reference Materials: For precision, linearity, and sensitivity studies, the "ground truth" is derived from the known concentrations of commercially available control materials and linearity standards.

Therefore, there were no human "experts" with specific qualifications (like radiologists) involved in establishing ground truth in the context of interpretation, but rather the performance of an already-approved, established diagnostic device.

4. Adjudication Method for the Test Set

No adjudication method as typically understood in studies involving human interpretation (e.g., 2+1, 3+1) was used or is applicable for this type of in-vitro diagnostic device. The comparison is objective, based on quantitative measurements. For patient comparison, the results from the GenChem device were compared statistically (least squares linear regression) against the results from the Beckman CX3 Synchron Analyzer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective assessments (e.g., radiologists interpreting images). The GenChem ISE Electrolyte Buffer is an in-vitro diagnostic reagent/buffer for an automated analyzer, thus human interpretation is not the primary output being evaluated. The device's performance is objective (numeric measurements of analytes).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the performance presented for precision, linearity, sensitivity, and patient comparison is standalone performance of the GenChem ISE Electrolyte Buffer when used with the specified analyzer (Beckman CX3 Synchron Analyzer and associated reagents). There is no "human-in-the-loop" component for the measurement process itself, other than the standard operation of the analyzer by trained lab personnel. The device itself (the buffer) is a reagent, not an algorithm, so the concept of an "algorithm only" performance applies to the entire analytical system with the new buffer.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for this device's validation is primarily:

Reference Measurement (Predicate Device): For patient comparison, the measurements obtained from the predicate Beckman CX3 Synchron Analyzer served as the reference standard.
Known Concentrations: For precision, linearity, and sensitivity, the known, assayed values of commercially available control materials and linearity standards were used.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the analytical performance of this IVD device.

8. The Sample Size for the Training Set

This document describes a pre-market notification (510(k)) for a medical device (reagent/buffer), not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's formulation and manufacturing processes are developed and optimized through R&D, but there is no "training phase" with a distinct dataset as there would be for an AI model.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" in the AI sense for this device. The chemical and performance characteristics are established through standard chemical and analytical development processes, not through machine learning.

Summary

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DEC 27 2004

510(k) SUMMARY K040977

1.0 Submitted By:

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Ste 107 Brea, CA 92821 Telephone: (714) 529-7125 FAX: (714) 529-3339

2.0 Date of Preparation: June 1, 2004

3.0 Regulatory Information:

3.1 Regulation section: GenChem Electrolyte Buffer 21 CFR § 862.1665 Electrode, Ion Specific, Sodium, Potassium, Chloride, CO2, Calcium
3.2 Clasification : Class II
3.3 Product Code: JGS
3.4 Panel: Clinical Chemistry (75)

4.0 Device Description:

5.0 a. Predicate Device Name: Electrode, Ion Specific, Sodium, Potassium, Chloride, CO2, Calcium
- b. Predicate K Number: K801896
- c. Comparison with Predicate: Both Reagents are similar in design, function and chemical principle as well as ingredient composition and concentration.
6.0 Performance Characteristics: All studies were performed on the Beckman CX3® Synchron Analyzer
- 6.1 Precision/Reproducibility: Within-Day and Day-to-Day precision was determined according to NCCLS EP5-A. Results are summarized below:

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Within-Day; N=60

S-1 S-2 S-3 U-1 U-2

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Day-To-Day (30 Days); N=60

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6.2 Linearity/assay reportable range:

Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results are shown below. Specimens exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.

	Intercept	Slope	R2	Sey	Range
Calcium	0.34	0.911	1.000	0.35	0.8 – 14.3 mg/dL
Na	2.37	0.968	1.000	2.61	0 – 200 mmol/L
K	-0.09	1.017	1.000	0.03	0.9 – 15.2 mmol/L
CL	-0.71	0.999	1.000	0.99	0 – 197 mmol/L
CO2	0.15	1.000	1.000	0.41	0 – 40 mmol/L

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The results show this method is linear as shown below:

Calcium	0.8 to 14.3 mg/dl
Chloride	0 to 150 mmol/L
Potassium	0.9 to 15.2 mmol/L
Sodium	0 to 200 mmol/L
Total CO2	0 to 40 mmol/L

6.3 SENSITIVITY:

The sensitivity of this methodology was documented through the repetitive assay of a serum control first with a known concentration and then diluting the sample until the minimum result was obtained and then run in replicates of 10 on the Beckman Synchron® System. Under the conditions described, the following limits of detection were established:

Analyte	Limit of Detection
Calcium	1.5 mg/dL
Sodium	10 mmol/L
Potassium	1.0 mmol/L
Chloride	15 mmol/L
Total CO2	5.0 mmol/L

6.4 Analytical Specificity:
Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with levels of sodium at 148 mmol/L, potassium at 5.2 mmol/L, chloride at 119 mmol/L, CO2 at 19 mmol/L, and calcium at 9.4 mg/dL. Stock solutions of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent. Only Sodium Heparin, Lithium Heparin and Ammonium Heparin up to 45 Units/mL are acceptable anticoagulants.

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7.0 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 CX3® System using GenChem and Beckman flow cell reagents, wash solutions and calibrators. Results were compared by least squares linear regression where X = Beckman Results and Y = GenChem Results.

Analyte Specimen	Unit	n	m	b	r	range
Calcium
Serum	mg/dL	80	0.989	0.0	0.985	7.1-10.6
Plasma	mg/dL	80	0.990	0.0	0.995	7.1-10.7
Urine	mg/dL	74	1.007	-0.2	0.998	2.4-15.2
Chloride
Serum	mmol/L	80	0.988	1.0	0.935	98 - 127
Plasma	mmol/L	80	0.998	0.8	0.985	98 - 127
Urine	mmol/L	78	1.049	-5.1	0.999	22-289
CSF	mmol/L	44	1.024	-3.4	0.985	113-152
Potassium
Serum	mmol/L	80	0.969	0.13	1.000	3.2-10.8
Plasma	mmol/L	80	0.987	0.15	1.000	3.2-10.8
Urine	mmol/L	80	0.993	0.01	1.000	3.5-136
Sodium
Serum	mmol/L	80	0.930	9.1	0.938	132-159
Urine	mmol/L	78	1.000	-0.3	1.000	17-288
Total CO2
Serum	mmol/L	80	0.949	1.2	0.953	9.5-29
Plasma	mmol/L	80	0.965	0.9	0.960	9.5-29

8.0 Expected Values/ Reference Range:

The expected values for calcium, chloride, potassium, sodium, and total CO2 are listed below. Use these ranges only as guides. Each laboratory should establish its own reference ranges.

Reference Ranges1

Analyte	Specimen	Conventional Units	SI Units
Calcium	Serum/Plasma	8.4 - 10.2 mg/dL	2.10 - 2.55 mmol/L
	Urine	100 - 300 mg/day	2.5 - 7.5 mmol/day
Chloride	Serum/Plasma	101 - 111 mmol/L	same
	Urine	110 - 250 mmol/day	same
	CSF	118 - 132 mmol/L	same
Potassium	Serum/Plasma	3.5 - 5.1 mmol/L	same
	Urine	25 - 125 mmol/day	same
Sodium	Serum/Plasma	136 - 145 mmol/L	same
	Urine	40 - 220 mmol/day	same
Total CO2	Serum/Plasma	22 - 28 mmol/L	same

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized wing segments. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 27 2004

C.C. Allain. Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Suite 107 Brea, CA 92821

K040977 Re:

Trade/Device Name: GenChem ISE Electrolyte Buffer Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JFL, JFP Dated: October 15, 2004 Received: October 15, 2004

Dear Dr. Allain:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/dsma/dsmamain.html.

Sincerely yours,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K040977

Device Name: GenChem ISE Electrolyte Buffer

Indications For Use:

A.berto C
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5100k K040977

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Regulation Number and Section

§ 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.