The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.

Device Description

The AVL 9180 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results.

In the blood, serum and QC measuring modes, the results for sodium and potassium are reported by default as flame photometry equivalent; chloride, ionized calcium and lithium are reported as ISE direct potentiometric values. The urine mode allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard modes allow for the measurement of aqueous standards and dialysate solutions and reports as ISE direct potentiometric values.

AI/ML Overview

The provided text describes the AVL 9180 Electrolyte Analyzer, an ion-specific electrolyte analyzer for measuring sodium, potassium, chloride, ionized calcium, and lithium. The submission focuses on demonstrating the substantial equivalence and performance of the new device compared to existing predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text (e.g., "correlation coefficient > 0.95"). Instead, the document implies that the device meets acceptance criteria if its performance is comparable to predicate devices and falls within "manufacturers claims and expectations." The core of the performance evaluation relies on correlation coefficients, slopes, and intercepts from comparative studies, demonstrating the agreement between the AVL 9180 and established methods.

The tables presented in the document are the reported device performance. I will present a summary table outlining the key performance metrics from the various comparative studies, grouped by parameter and comparator.

Parameter	Performance Metric (Type of Study)	Reported Value / Range	Indication of Acceptance
Sodium (Aqueous Solutions)	Correlation Coefficient (Linearity)	0.99995	Excellent linearity
	Slope (Linearity)	0.99993	Close to ideal slope of 1
	Intercept (Linearity)	0.0128	Close to ideal intercept of 0
Potassium (Aqueous Solutions)	Correlation Coefficient (Linearity)	0.99919	Excellent linearity
	Slope (Linearity)	0.99838	Close to ideal slope of 1
	Intercept (Linearity)	0.0119	Close to ideal intercept of 0
Chloride (Aqueous Solutions)	Correlation Coefficient (Linearity)	0.99994	Excellent linearity
	Slope (Linearity)	0.97556	Close to ideal slope of 1
	Intercept (Linearity)	-0.1775	Close to ideal intercept of 0
Ionized Calcium (Aqueous Solutions)	Correlation Coefficient (Linearity)	0.99980	Excellent linearity
	Slope (Linearity)	1.01552	Close to ideal slope of 1
	Intercept (Linearity)	-0.0078	Close to ideal intercept of 0
Lithium (Aqueous Solutions)	Correlation Coefficient (Linearity)	0.99985	Excellent linearity
	Slope (Linearity)	0.99850	Close to ideal slope of 1
	Intercept (Linearity)	0.0087	Close to ideal intercept of 0
Sodium (Serum vs. Flame Absorbance)	Correlation Coefficient	0.9908	Very good correlation
	Slope	0.9617	Close to ideal slope of 1
Potassium (Serum vs. Flame Absorbance)	Correlation Coefficient	0.9991	Excellent correlation
	Slope	1.0249	Close to ideal slope of 1
Lithium (Serum vs. Flame Absorbance)	Correlation Coefficient	0.9822	Very good correlation
	Slope	0.9803	Close to ideal slope of 1
Sodium (Serum vs. ISE Direct Potentiometry - AVL 983)	Correlation Coefficient	0.9992	Excellent correlation
	Slope	0.9895	Close to ideal slope of 1
Potassium (Serum vs. ISE Direct Potentiometry - AVL 983)	Correlation Coefficient	0.9996	Excellent correlation
	Slope	1.0223	Close to ideal slope of 1
Chloride (Serum vs. ISE Direct Potentiometry - AVL 983)	Correlation Coefficient	0.9995	Excellent correlation
	Slope	0.9631	Close to ideal slope of 1
Ionized Calcium (Serum vs. ISE Direct Potentiometry - AVL 984)	Correlation Coefficient	0.9960	Excellent correlation
	Slope	0.8898	Good correlation, slightly lower slope
Lithium (Serum vs. ISE Direct Potentiometry - AVL 985)	Correlation Coefficient	0.9985	Excellent correlation
	Slope	0.9923	Close to ideal slope of 1
Sodium (Serum vs. Flame Correlation - AVL 9130, 9140)	Correlation Coefficient	0.9856	Very good correlation
Potassium (Serum vs. Flame Correlation - AVL 9130, 9140)	Correlation Coefficient	0.9994	Excellent correlation
Chloride (Serum vs. Flame Correlation - AVL 9130, 9140)	Correlation Coefficient	0.9989	Excellent correlation
Ionized Calcium (Serum vs. Flame Correlation - AVL 9130, 9140)	Correlation Coefficient	0.9954	Excellent correlation
Sodium (Urine vs. direct ISE - AVL 983)	Correlation Coefficient	0.9973	Excellent correlation
	Slope	1.0173	Close to ideal slope of 1
Potassium (Urine vs. direct ISE - AVL 983)	Correlation Coefficient	0.9976	Excellent correlation
	Slope	1.0312	Close to ideal slope of 1
Chloride (Urine vs. direct ISE - AVL 983)	Correlation Coefficient	0.9972	Excellent correlation
	Slope	0.9817	Close to ideal slope of 1
Sodium (Urine vs. Flame Absorbance - IL 943)	Correlation Coefficient	0.9901	Very good correlation
	Slope	0.9173	Good correlation, slightly lower slope
Potassium (Urine vs. Flame Absorbance - IL 943)	Correlation Coefficient	0.9976	Excellent correlation
	Slope	1.0312	Close to ideal slope of 1
Chloride (Urine vs. Chloridometry - Labconco Digital)	Correlation Coefficient	0.9972	Excellent correlation
	Slope	0.9817	Close to ideal slope of 1
Sodium (Clinical vs. KODAK Ektachem XR700)	Correlation Coefficient	0.9495	Good correlation
Potassium (Clinical vs. KODAK Ektachem XR700)	Correlation Coefficient	0.9873	Very good correlation
Chloride (Clinical vs. KODAK Ektachem XR700)	Correlation Coefficient	0.9762	Very good correlation
Clinical Field Tests (example data presented)	No difference in mean values	P < 0.05	Meets statistical equivalence

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

Aqueous Linearity Standards: 300 samples for Sodium, Potassium; 100 samples for Chloride, ionized Calcium, Lithium. Data provenance: Gravimetrically prepared from N.I.S.T. traceable salts (non-clinical, laboratory setting).
Serum Linearity (vs. Flame Absorbance): 50 samples for Sodium, Potassium; 15 samples for Lithium. Data provenance: Commercially prepared serum linearity standards and random patient serum samples (non-clinical, likely laboratory setting).
Serum Linearity (vs. ISE Direct Potentiometry - AVL 983, 984, 985): 50 samples for Sodium, Potassium, Chloride, ionized Calcium; 15 samples for Lithium. Data provenance: Commercially prepared serum linearity standards and random patient serum samples (non-clinical, likely laboratory setting).
Serum Linearity (vs. ISE Direct Potentiometry with flame correlation - AVL 9130, 9140): 50 samples for Sodium, Potassium, Chloride, ionized Calcium. Data provenance: Commercially prepared serum linearity standards and random patient serum samples (non-clinical, likely laboratory setting).
Urine Linearity (vs. direct ISE - AVL 983): 56 samples for Sodium, Potassium, Chloride. Data provenance: Random patient urine specimens (non-clinical, likely laboratory setting).
Urine Linearity (vs. Flame Absorbance - IL 943): 56 samples for Sodium, Potassium. Data provenance: Random patient urine specimens (non-clinical, likely laboratory setting).
Urine Linearity (vs. Chloridometry - Labconco Digital): 56 samples for Chloride. Data provenance: Random patient urine specimens (non-clinical, likely laboratory setting).
Clinical Field Tests:
- Vs. KODAK Ektachem XR700: 103 samples for Sodium, Potassium, Chloride.
- Vs. other unspecified predicate devices: 102 samples for Sodium, Potassium, Chloride, ionized Calcium in one comparison; 102 samples for Sodium, Potassium, ionized Calcium in another; 104 samples for Lithium in another; 15 samples for Lithium in another comparison.
- Data provenance: "remnant from patient specimens collected for routine analysis on existing instrumentation" in a clinical setting. This indicates prospective or retrospective use of patient data from a clinical environment. The country of origin is not specified but presumably the USA, given the 510(k) submission to the FDA.

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

The document does not mention the use of experts to establish ground truth for the test sets. The ground truth is established by the measurements from:

N.I.S.T. traceable salts (for aqueous linearity).
Predicate devices which are recognized and established methods (Flame Absorbance Emission Spectroscopy, existing AVL ISE analyzers, Labconco Digital Chloridometer, KODAK Ektachem XR700).

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The ground truth is established by the specified reference methods/predicate devices.

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

No, an MRMC comparative effectiveness study was not done. The device is an automated electrolyte analyzer, not an imaging device requiring human interpretation, so this type of study is not applicable.

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

Yes, the studies presented are standalone performance evaluations of the AVL 9180 Electrolyte Analyzer. The device is a self-contained unit that performs measurements automatically ("The analyzer automatically processes the sample through the necessary steps"). The clinical field tests also state "operated by personnel trained to perform and report these analyses," indicating the device is used in a standalone manner with trained operators.

7. The Type of Ground Truth Used

The ground truth used for the studies is:

Gravimetrically prepared N.I.S.T. traceable standards (for aqueous linearity).
Measurements from legally marketed predicate devices (Flame Absorbance Emission Spectroscopy, existing AVL 983, AVL 984, AVL 985, AVL 9130, AVL 9140 Electrolyte Analyzers, IL 943 Flame Photometer, Labconco Digital Chloridometer, KODAK Ektachem XR700). These predicate devices represent established and accepted methods for electrolyte measurement, serving as the de facto "ground truth" for demonstrating equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning. The AVL 9180 is a microprocessor-based instrument using ion-selective electrodes, which relies on electrochemical principles rather than machine learning models that require distinct training and test sets. The "calibration" mentioned is an internal process for the instrument's electrodes and sensors, not a machine learning training phase.

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

Since there is no explicit mention of a "training set" in the machine learning sense, this question is not applicable. However, for the instrument's calibration (which can be considered analogous to "training" in a broad sense for analytical instruments), the document mentions:

"A 2-point calibration is performed automatically every 4 hours in READY mode, and a 1-point calibration is performed automatically with each measurement."
"Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable salts and measured on each of six AVL 9180 instruments..."

This implies that N.I.S.T. traceable salts and potentially internal calibration solutions are used to establish the "ground truth" for the device's internal calibration processes.

Summary

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K961458

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510(k) Summary JUN | 2 1998

(a) (1) Submitter's name, address AVL Scientific Corporation 33 Mansell Court Roswell, GA 30076

Contact Person

10 April 1996

Randy Byrd Ouality Assurance Manager (770) 587-4040 x 631

Date of preparation of this summary:

(2) Device trade or proprietary name:

AVL 9180 Electrolyte Analyzer

Device common or usual name or classification name

Ion-specific electrolyte analyzer for sodium, potassium and chloride or ionized calcium or lithium.

Product Nomenclature	Classification Number	Class	Panel
ELECTRODE, ION-SPECIFIC, CALCIUM	75 JFP	II	CHEMISTRY
ELECTRODE, ION-SPECIFIC, CHLORIDE	75 CGZ	II	CHEMISTRY
FLAME PHOTOMETER, LITHIUM	75 JIH	II	TOXICOLOGY
ELECTRODE, ION-SPECIFIC, POTASSIUM	75 CEM	II	CHEMISTRY
ELECTRODE, ION-SPECIFIC, SODIUM	75 JGS	II	CHEMISTRY

(3) Substantial Equivalence

The AVL 9180 is an improved design of our ISE electrolyte analyzer line to provide the user an ability to only exchange electrodes to change configuration between sodium, potassium and chloride to sodium, potassium and ionized calcium or sodium, potassium and lithium. The 9180, configured for sodium, potassium and chloride is equivalent to the AVL 983 Na/K/Cl Analyzer [K861087]; for sodium, potassium and ionized calcium, to the AVL 984 Na/K/iCa Analyzer [K862819] and; for sodium, potassium and lithium to the AVL 985 Na/K/Li Analyzer [K870657]. Additionally, for sodium, potassium and lithium the AVL 9180 is substantially equivalent to the I.L. Model 943 Flame Emission Photometer and for chloride, to the Labconco Digital Chloridometer.

(4) Description of the new device

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ

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(2) Intended use of the device.

(6) Technological characteristics of the device.

Principles of Measurement

The principles of measurement used in the AVL 9180 Electrolyte Analyzer are identical to those principles existing in the electrolyte analyzers to which substantial equivalence is claimed in paragraph (a)(3) above.

Calibration

The AVL 9180 contains software which permits operation in one of six parameter configurations: Na+/K+/Ca++, Na+/K+/Cl-, Na+/K+/Li+, Na+/K+, Na+/Li+ or Li+. A 2-point calibration is performed automatically every 4 hours in READY mode, and a 1-point calibration is performed automatically with each measurement.

Technical Specifications

Measured Values

Parameter	Range	Display Resolution	units
whole blood, serum, plasma, dialysate and aqueous solutions
Sodium	40 - 205	0.1	mmol/L
Potassium	1.5 - 15	0.1 or 0.01	mmol/L
Chloride	50 - 200	0 or 0.1	mmol/L
ionized Calcium	0.2 - 5.0	0.01 or 0.001	mmol/L
Lithium	0.1 - 6.0	0.01 or 0.001	mmol/L
urine
Sodium	1-300	0	mmol/L
Potassium	4.5 - 120	0.1	mmol/L
(60 - 120 with additional dilution)
Chloride	1 - 300	0	mmol/L

Image /page/1/Picture/13 description: The image shows a drawing of an oval shape with the number 14 written inside. The number 14 is written in a simple, handwritten style. The oval shape appears to be hand-drawn as well, with slightly uneven lines.

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المشاهدة

المقاطع
المقابل
المقابل المستوى
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Operating Conditions

• Minimum Sample Size:	95 µL
• Sample Type:	heparinized whole blood, serum, plasma, urineaqueous standards and acetate or bicarbonatedialysate solutions
• Sample Application:	syringe, capillary or AVL Microsampler,collection tube or sample cup
• Sample Input	automatic aspiration
• Ambient Temperature:	+15 - +32 °C (59 - 90 °F)
• Relative Humidity:	5% to 95% (non-condensing)
• Type of Measurement:	direct potentiometry

Data Management

· Printout	...............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................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Electrical Supply

· Voltage	100 - 240 VAC (50-60 Hz)
· Power Consumption	1.4 VA max., 375 max.

Dimensions and Weight

· Height x width x depth 13.2 x 12.4 x 12.0 inches (33.5 x 31.5 x 29.5 cm)
Weight

Classifications

• Safety category	I
• Device type	B (according to ÖVE-MG/EN 60601-1, IEC 601-1)
• Mode of operation	continuous operation
• Protection classification	IP 20
• Explosion protection	the device is not designed for operation in explosive environments
• Approvals	CSA, IEC 1010 (TÜV/GS), CE

(b) (1) Summary of nonclinical tests submitted with the premarket notification for the device. Precision

Typical Within-Run (Sw) Between-Day (Sos) and Total (ST) Precision is determined from 2 runs per day with 2 replicates per run for 20 days on two model AVL 9180 analyzers in each of its three main configurations using samples of each of the specimen types suitable for measurement on the 9180.

$$\langle \hat{\mathfrak{o}}_{\cdot} \rangle$$

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المقامة

المستق

Linearity in Aqueous Standard Solutions

Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable salts and measured on each of six AVL 9180 instruments, two of each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li.

Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	0.99993	0.0128	0.99995	0.666	51 - 196	300
Potassium	0.99838	0.0119	0.99919	0.194	2.0 - 12.6	300
Chloride	0.97556	-0.1775	0.99994	0.674	56 - 194	100
ionized Calcium	1.01552	-0.0078	0.99980	0.037	0.4 - 3.3	100
Lithium	0.99850	0.0087	0.99985	0.038	0.3 - 5.3	100

Linearity in Serum

Linearity in serum was established with the analysis of two specimen sets in nonclinical tests: commercially prepared serum linearity standards for sodium, chloride and potassium with normal protein content, and a group of random patient serum samples. All samples were analyzed in pairs on each of two of AVL 9180 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li. and in pairs on each of several instrument types for comparison to various methods:

vs. Flame Absorbance Emission Spectroscopy (IL 943 Flame Photometer)

Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	0.9617	5.83	0.9908	2.04	104 - 178	50
normalized to Na=140		0.47
Potassium	1.0249	0.015	0.9991	0.075	1.8 - 11.5	50
normalized to K=4.0		0.11
Lithium	0.9803	0.011	0.9822	0.028	0.11 - 0.71	15

vs. ISE Direct Potentiometry (AVL 983, AVL 984, AVL 985 Electrolyte Analyzers)

Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	0.9895	-6.35	0.9992	0.61	110 - 186	50
Potassium	1.0223	-0.25	0.9996	0.05	2.0 - 11.6	50
Chloride	0.9631	-1.01	0.9995	0.51	70 - 152	50
ionized Calcium	0.8898	0.107	0.9960	0.021	0.67 - 1.66	50
Lithium	0.9923	0.008	0.9985	0.010	0.11 - 0.71	15

vs. ISE Direct Potentiometry with flame correlation (AVL 9130, AVL 9140 Electrolyte Analyzers)

Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	0.9856	-2.02	0.9856	1.21	104 - 179	50
Potassium	0.9992	0.02	0.9994	0.05	1.9 - 11.8	50
Chloride	1.0026	-5.31	0.9989	0.73	70 - 152	50
ionized Calcium	1.0023	0.040	0.9954	0.022	0.62 - 1.54	50

Image /page/3/Picture/14 description: The image contains a drawing of the number 2 inside of a circle. The number 2 is written in a simple, handwritten style. The circle is also drawn in a simple style, and it encloses the number 2. The drawing is in black and white.

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Linearity in Urine

Linearity in urine was evaluated with the analysis of random patient urine specimens on two. AVL 9810 Electrolyte Analyzers in the Na/K/Cl configuration and, in duplicate on two AVL 983 Na/K/Cl Electrolyte Analyzers for sodium, potassium and chloride; on a IL 943 Flame Photometer for sodium and potassium; and on a Labconco Digital Chloridometer for chloride.

vs. direct ISE (AVL 983) in urine

Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	1.0173	-7.4382	0.9973	5.55	4 - 262	56
Potassium	1.0312	-0.1539	0.9976	2.24	6 - 147	56
Chloride	0.9817	2.4630	0.9972	5.64	16 - 299	56

vs. flame absorbance emission spectroscopy (IL 943 Flame Photometer) in urine

Parameter	Slope	Intercept	Coefficient	Sy'x	Range	n
Sodium	0.9173	0.5627	0.9901	10.64	7 - 285	56
Potassium	1.0312	-0.1539	0.9976	2.24	6 - 147	56

vs. chloridometry (Labconco Digital) Chloridometer in urine

Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Chloride	0.9817	2.4630	0.9972	5.64	16 - 299	56

(b) (2) Summary of clinical tests submitted with the premarket notification for the device. Three field tests were conducted to demonstrate the correlation of the AVL 9180 to legally marketed predicate devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed in these tests were remnant from patient specimens collected for routing analysis on existing instrumentation.

In all evaluations, there was no difference in mean values ($P$<0.05) obtained on measurement by the AVL 9180 and the predicate device. The table below provides data representative of that collected in these field tests.

vs. thin-film slide; KODAK Ektachem XR700 in serum

Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	1.0459	-6.6196	0.9495	1.67	125 - 158	103
Potassium	1.0895	-0.2740	0.9873	0.10	2.8 - 6.2	103
Chloride	0.9505	6.2577	0.9762	1.32	85 - 125	103

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Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	0.9208	10.1267	0.9485	1.19	112-142	102
Potassium	0.9820	0.0879	0.9933	0.16	3.2-12.3	102
Chloride	0.8346	13.3572	0.9674	1.45	83-118	102
ionized Calcium	1.0020	0.0800	0.9783	0.02	0.78-1.37	102
vs. direct ISE (AVL 984 Electrolyte Analyzer) in whole blood
Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Sodium	0.9918	-6.4874	0.9682	0.94	123-149	102
Potassium	0.9671	-0.0380	0.9974	0.10	3.3-12.8	102
ionized Calcium	0.9491	0.0374	0.9825	0.02	0.87-1.47	102
vs. direct ISE (AVL 985 Electrolyte Analyzer) in whole blood
Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Lithium	1.0799	-0.0203	0.9986	0.03	0.19-3.34	104
vs. flame absorbance emission spectroscopy (IL 943 Flame Photometer) in serum
Parameter	Slope	Intercept	CorrelationCoefficient	Sy*x	Range	n
Lithium	0.9720	0.0163	0.9957	0.02	0.23-1.13	15

Conclusions drawn from the clinical and nonclinical trials. (b) (3)

Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and nonclinical trials demonstrates that the AVL 9180 in any of the available configurations for measurement, is safe and effective. There is no significant difference in the measurement values obtained on whole blood, serum or urine with the AVL 9180 and those obtained with predicate devices in this study and the precision and linearity demonstrated both in clinical and non clinical trials is within the manufacturers claims and expectations.

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.