The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.

The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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.

The SMARTLYTE Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. 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).

The SMARTLYTE Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Device Description

The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended . quality control material to be used daily.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them, based on your requested format:

Acceptance Criteria and Device Performance Study for SMARTLYTE Electrolyte Analyzer

The SMARTLYTE Electrolyte Analyzer is an automated, microprocessor-controlled device using ion-selective electrodes to measure sodium, potassium, chloride, calcium, and lithium in various sample types, including dialysate. The study aimed to demonstrate the substantial equivalence of the SMARTLYTE to its predicate device, the AVL 9180 (K961458), particularly for dialysate measurements, which represent a modification from previously cleared uses.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance characteristics or defined in the "Reproducibility" section as maximum allowable CVs or SDs. The reported device performance is from the "Precision Dialysate" and "Dialysate Comparison" sections.

Note on Acceptance Criteria: The document primarily compares the SMARTLYTE's performance to the predicate device's expected values and establishes its own internal precision targets. For the method comparison, "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04" serves as a key acceptance criterion for the clinical claims (correlation with a predicate device). For precision, specific CV/SD targets are given.

Parameters	Matrix	Acceptance Criteria (Predicate/Target)	Reported Device Performance (SMARTLYTE)
Precision
Na+	Dialysate	Within Run C.V. ≤ 1% Between Run C.V. ≤ 2%	Within Run C.V.: 0.32-0.47% Between Run C.V.: 0.32-0.54%
K+	Dialysate	Within Run C.V. ≤ 2% Between Run C.V. ≤ 3%	Within Run C.V.: 0.28-0.87% Between Run C.V.: 0.88-1.27%
Cl-	Dialysate	Within Run C.V. ≤ 2% Between Run C.V. ≤ 3%	Within Run C.V.: 0.24-0.89% Between Run C.V.: 0.53-1.44%
Ca++	Dialysate	Within Run SD ≤ 0.02 Between Run SD ≤ 0.06	Within Run SD: 0.0087-0.0155 (CV not calculated in source) Between Run SD: 0.0076-0.0226 (CV not calculated in source)
Na+	Urine	Within Run C.V. ≤ 5% Between Run C.V. ≤ 5% (Predicate: ≤ 7%)	(Not explicitly reported in this document for Urine; previously cleared K082462)
K+	Urine	Within Run C.V. ≤ 5% Between Run C.V. ≤ 5%	(Not explicitly reported in this document for Urine; previously cleared K082462)
Cl-	Urine	Within Run C.V. ≤ 5% Between Run C.V. ≤ 5%	(Not explicitly reported in this document for Urine; previously cleared K082462)
Linearity	Dialysate	R-squared ≈ 0.99 (implied by "good correlation")	Sodium: 0.9995 Potassium: 0.9976 Chloride: 0.9998 Calcium: 0.9972
		Slope ≈ 1 (implied)	Sodium: 0.9806 Potassium: 1.0031 Chloride: 0.9996 Calcium: 0.9857
		Intercept ≈ 0 (implied)	Sodium: 2.53 Potassium: -0.37 Chloride: 1.60 Calcium: 0.06
Method Comparison (to predicate AVL 9180)	Dialysate	R > 0.99, Slope 0.96-1.04 (Stated by manufacturer)	Sodium: R=0.9989, Slope=1.0183 Potassium: R=0.9996, Slope=0.9882 Chloride: R=0.9966, Slope=0.9825 Calcium: R=0.9956, Slope=1.0021
Measuring Range	Dialysate	Na: 40-205 mEq/L K: 1.7-15 mEq/L Cl: 50-200 mEq/L Ca: 0.3-5.5 mmol/L (Predicate range)	Na: 40-200 mEq/L (Linearity confirmed: 24-205); Method comparison supported: 40-205 mEq/L K: 1.7-15 mEq/L (Linearity confirmed: 1.4-15.1); Method comparison supported: 1.7-11 mEq/L Cl: 50-200 mEq/L (Linearity confirmed: 40-202); Method comparison supported: 50-205 mEq/L Ca: 0.3-5.5 mmol/L (Linearity confirmed: 0.4-5.0); Method comparison supported: 0.3-5.5 mmol/L

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

Precision (Dialysate):
- Within-run: 30 replicates for each of three dialysate samples (low, mid, high concentrations) per measurand.
- Between-run (Total precision): 40 replicates (4 groups of 10 replicates over 10 days) for each of three dialysate samples per measurand.
Linearity (Dialysate):
- Sodium: 34 samples
- Potassium: 36 samples
- Chloride: 34 samples
- Calcium: 48 samples
Method Comparison (Dialysate):
- Sodium: 43 samples
- Potassium: 56 samples
- Chloride: 51 samples
- Calcium: 43 samples

Data Provenance: The document implies these were prospective studies conducted to support the 510(k) submission for the specific device modifications. No explicit country of origin is stated for data collection, but given it's a US FDA submission, it's typically assumed to be North American or adhering to international standards accepted by the FDA. The samples were "dialysates collected" and some were "spiked or diluted" to span the measurement ranges, suggesting a mix of clinical and artificially prepared samples. Prior data for whole blood, serum, plasma, and urine were "previously cleared (K082462)".

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

Not applicable. This is an in-vitro diagnostic device measuring analytes. The "ground truth" for the test set is established by the reference methods or the predicate device that the SMARTLYTE is compared against, not by human expert assessment of images or clinical cases. The reference for comparison would be the AVL 9180 predicate device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 for consensus among experts) are used in studies involving human interpretation or subjective assessments. This study evaluates the analytical performance of an IVD device against a predicate or defined analytical targets.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases with and without AI assistance to measure a change in human performance (e.g., diagnostic accuracy, reading time). The SMARTLYTE is an automated IVD device; it does not involve human readers interpreting output in the same way an imaging AI would.

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

Yes, the studies described (precision, linearity, method comparison) represent standalone performance of the SMARTLYTE device. The device operates automatically to measure analyte concentrations. The "human-in-the-loop" aspect is limited to operating the device and collecting samples, not interpreting an AI's output to make a diagnosis.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies can be defined as:

Reference Intervals/Expected Values: For linearity studies, expected values based on known dilutions of stock solutions serve as the ground truth.
Predicate Device Measurements: For the method comparison study, the measurements from the predicate device (AVL 9180) on the same dialysate samples served as the comparative ground truth.
Internal Precision Targets: For the precision studies, the acceptance criteria (max CV/SD) are internal performance targets, and the reported values are measured against these.

8. The Sample Size for the Training Set

Not applicable. The SMARTLYTE Electrolyte Analyzer is an IVD device based on ion-selective electrode technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its hardware, chemistry, and pre-programmed algorithms, which are calibrated and verified through analytical studies.

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

Not applicable, as there is no "training set" in the context of this device's technology. The device uses established physical and chemical principles (ion-selective electrodes). Calibrations are performed using certified calibration fluids.

Summary

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(1) Submitted by:

Diamond Diagnostics 333 Fiske St. Holliston, MA 01746

(2) Contact Person:

Liann Voo, Director of Quality Assurance and Scientific Development Phone: 508-429-0450 (x 351) Fax: 508-429-0452 lvoo@diamonddiagnostics.com E-mail:

(3) Summary Prepared:

March 26, 2012

(4) Device Trade Name:

SMARTLYTE Electrolyte Analyzer

(5) Regulatory Information

Description	CFR Section	Device Class	Product Code
Sodium Test System	862.1665	Class II	JGS
Potassium Test System	862.1600	Class II	CEM
Chloride Test System	862.1170	Class II	CGZ
Calcium Test System	862.1145	Class II	JFP
Lithium Test System	862.3560	Class II	JIH

(6) Predicate Devices:

Description	510(k)	Measurand
AVL 9180	K961458	Sodium, Potassium, Chloride, Calcium and Lithium

Statement of Technology Characteristics of the Device Compared to Predicate Device

Operating Principle	Predicate Device	SMARTLYTE
Potentiometric Na+, K+, Cl-, Ca++, Li+	K961458	Same

(7) Indications for Use:

AUG 3 0 2012

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(8) Device Descriptions:

(9) Technological Characteristics of the Device:

Principal of Measurement

The principles of measurements used in the SMARTLYTE Electrolyte Analyzer are identical to those principles existing in the current SMARTLYTE electrolyte analyzer (K082462) and AVL 9180 (K961458) and are substantially equivalent to the K823480 (IL Flame Photometer) and K810615 (925 Chloridometer).

The SMARTLYTE measures sodium, potassium, chloride and calcium in dialysate using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium and calcium each incorporate neutral carrier ionophore membranes which are highly selective for their respective ions. The chloride contains an ionophore covalently bound to a substrate which is sensitive to negatively charged ions. The potential of each electrode is measured relative to a fixed, stable reference established by a silver/silver chloride electrode in concentrated salt solution. The measured potential varies with the concentration of the ion sensed by the electrode.

Comparison to Predicate Devices:

The software has been modified to add a Dialysate mode. In addition the hardware was changed to allow saving of more than one sample or calibration result and increased QC storage capacity as well. Moreover, an RFID board was added to the CPU board so that individual reagent packs can be monitored for fluid consumption. All other functionality has remained unchanged from the Predicate SMARTLTYE. The Dialysate Mode added is similar to the 9180 Bicarbonate Dialysate Mode.

The table below compares the Candidate Device to its predicates.

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	Candidate Device	Predicate
Trade/proprietary name	Diamond Electrolyte Analyzer	Roche Electrolyte Analyzer
Model number	SMARTLYTE	9180
Manufacturer	Diamond Diagnostics Corp	Roche Diagnostics GmBh
510(k)/PMA reference number		K961458
Intended use	Sodium, Potassium, Chloride, Calcium, LithiumDetermination	Same
Sample Type	Blood, serum, plasma, urine, aqueous QC, Dialysate	Also has Acetate Dialysate Mode
Measurement Principle	Ion Selective Electrodes	Same
Analysis time	57 sec	Same
Measurement Range, Whole Blood, Plasma, Serum, Dialysate	Na 40 - 200 mEq/LK 1.7 - 15 mEq/LCl 50 - 200 mEq/LCa 0.3 - 5 mmol/LLi 0.2 - 5.5 mEq/L	40 - 205 mEq/L1.5 - 15 mEq/L50 - 200 mEq/L0.2 - 5.0 mmol/L0.1 - 6.0 mEq/L
Measurement Range, Urine	Na 3 - 300 mEq/LK 5 - 120 mEq/LCl 15 - 300 mEq/L	1 - 300 mEq/L4.5 - 120 mEq/L1 - 300 mEq/L
Expected, within run CV	≤ 1 %	≤ 1 %
Expected, between run CV	≤ 2 %	≤ 1 %
Expected, within run CV	≤ 1.5 %	≤ 2 %
Expected, between run CV	≤ 3 %	≤ 3 %
Expected, within run CV	≤ 1 %	≤ 1 %
Expected, between run CV	≤ 3 %	≤ 1 %
Expected, within run sd	≤ 0.02	≤ 0.02
Expected, between run sd	≤ 0.06	≤ 0.04
Expected, within run sd	≤ 0.03	≤ 0.02
Expected, between run sd	≤ 0.09	≤ 0.08
Urine Precision, Na
Expected, within run CV	≤ 5 %	Same
Expected, between run CV	≤ 5 %	≤ 7 %
Urine Precision, K
Expected, within run CV	≤ 5 %	Same
Expected, between run CV	≤ 5 %	Same
Urine Precision, Cl
Expected, within run CV	≤ 5 %	Same
Expected, between run CV	≤ 5 %	Same
Calibration	Automatic and on Demand	Same
Reagent Pack	Standard A 350 mlStandard B 85 mlStandard C 85 mlReference Solution 85 mlWaste bagR/W RFID Tag for monitoring individual fluid packconsumption
		No RFID Tag
Results Storage	Measurement results, 1000QC Levels 1, 2, 3 results, each 500Calibration Results, 5	Measurement results, 1QC Levels 1, 2, 3 results, total 35Calibration Results, 1
Output	32 character, 2 line alphanumeric displaythermal printerRS-232 Serial portUSB ports (2)RFID Board to R/W RFID Tag	SameSameSame
Power	100-115 - VAC 50-60 Hz, 0.8 Aor	SameSame
	220-VAC 50/60 Hz, 0.4 A	Same

11 - 11

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Calibration:

The SMARTLYTE performs a 2-point calibration (3-point calibration if lithium) every 4 hours. The software also permits calibration on demand. A 1-point calibration is performed automatically with each measurement.

Technical Specifications: Analyzer tests samples for Na //K //Cl/Ca /Li

Sample Types: Whole Blood, Serum, Plasma, Urine; Dialysate - .

Sample Size: 95uL blood, plasma, serum, dialysate 95uL 1:3 dilution of urine .

Measurement Range:	Parameter Matrix	Specified range
	Na+B/P/S/D/Q	40 - 200 mEq/L
	U	1 - 300 mEq/L
	K+B/P/S/D/Q	1.5 - 15 mEq/L
	U	5 - 120 mEq/L
		(60 - 120 mEq/L with additional dilutions)
	Cl-B/P/S/D/Q	50 - 200 mEq/L
	U	1 - 300 mEq/L
	iCa++B/P/S/D/Q	0.3 - 5 mmol/L
	Li+B/P/S/Q	0.2 - 5.5 mEq/L

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

B = Whole blood	P = Plasma	S = Serum
Q = Aqueous QC	U = Urine	D = Dialysate

Display Resolution:

Blood, Plasma, Serum, Dialysate, Aqueous QC

Na+: 0.1 mEq/L
K+: 0.1 mEq/L or 0.01 mEq/L
Cl-: 0.1 mEq/L
Ca++: 0.1 mmol/L or 0.01 mmol/L
Li+: 0.1 mEq/L or 0.01 mEq/L

Urine

Na*: 0 mEq/L K*: 0.1 mEq/L Cl. 0 mEq/L

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Reproducibility:

		Blood, Plasma, Serum, Dialysate		Kt
Within Range (n=30)Between Run (10 days)		NaC.V. ≤ 1%C.V. ≤ 2%	C.V. ≤ 1.5%C.V. ≤ 3%	Cl.C.V. ≤ 2%C.V. ≤ 3%	Ca**SD ≤ 0.02SD < 0.06	LitSD < 0.03SD < 0.09
	Urine
Within Range (n=30)		Na*C.V. ≤ 5%	KC.V. ≤ 5%	Cl.C.V. ≤ 5%
		Between Run (10 days)	C.V. ≤ 5%	C.V. ≤ 5%	C.V. ≤ 5%
Analysis Time		57 seconds
CalibrationEvery 4 hours, on demand2 point calibration Na,K,CF,Ca*3 point calibration Li
Power

5 Hz, 6 A or 120 VAC 220-240 VAC 24 Hz, 2 A (Factory set)

Size and Weight

12.4" (31.5cm) W x 13.2" (33.5cm) H x 11.6" (29.5cm) D, 13 lbs. (<6 kg)

(10) Summary of nonclinical tests submitted with the premarket notification for device.

Precision - Whole blood, serum, plasma and urine were previously cleared (K082462).

Within run precision was calculated from three dialysate samples for each measurand. The sample concentrations were at the low and high end of reference ranges and near the mid point range. The protocol called for running 30 replicates of each sample without calibration between measurements. The replicates were run consecutively in one day.

	Within Run
Na+	C.V. ≤ 1%
K+	C.V. ≤ 2%
Cl-	C.V. ≤ 2%
Ca++	SD ≤ 0.02

Total precision was calculated for 3 samples with concentrations spanning the reportable range. The dialysate samples were run in groups of 10, with a calibration between each group of 10 replicates. This procedure was adopted due to the inherent instability of Calcium in the carbonate/bicarbonate environment which would result in Ca shifts.

Dialysate

	Between Run
Na+	C.V. ≤ 2%
K+	C.V. ≤ 3%

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Cl-	C.V. ≤ 3%
Ca++	SD ≤ 0.06

Precision Dialysate, mEq/L

Within Run	Na+	K+	Cl-	Ca++		Na+	K+	Cl-	Ca++		Na+	K+	Cl-	Ca++
Mean	122.45	2.7073	83.93	0.8013	Mean	139.56	4.0400	107.32	1.2491	Mean	158.12	6.7653	123.05	1.7015
SD	0.39	0.0235	0.75	0.0087	SD	0.45	0.0111	0.35	0.0143	SD	0.74	0.0265	0.29	0.0155
%CV	0.32	0.87	0.89		%CV	0.32	0.28	0.33		%CV	0.47	0.39	0.24
N	30	30	30	30	N	30	30	30	30	N	30	30	30	30
Run to Run	Na+	K+	Cl-	Ca++		Na+	K+	Cl-	Ca++		Na+	K+	Cl-	Ca++
Mean	122.41	2.7243	83.48	0.7975	Mean	140.59	4.0718	107.91	1.2347	Mean	158.77	6.7618	123.55	1.6788
SD	0.40	0.0347	1.20	0.0076	SD	0.76	0.0359	0.58	0.0158	SD	0.80	0.0693	0.72	0.0226
%CV	0.32	1.27	1.44		%CV	0.54	0.88	0.53		%CV	0.51	1.02	0.59
N	40	40	40	40	N	40	40	40	40	N	40	40	40	40

Linearity - Whole blood, serum, plasma and urine were previously cleared (K082462). Linearity was evaluated by preparing stock solutions with high concentrations of Na , CI and Ca in dialysate. These stocks were diluted to concentrations across the measuring ranges of each analyte and matrix. Linear regression was performed on the results using expected values based on the stock sample dilution. The results are shown below.

Dialysate, Measured compared to Expected Values, mEg/L

Parameter	Slope	Intercept	R2	Range	Stevx	n
Sodium	0.9806	2.53	0.9995	24 – 205	1.12	34
Potassium	1.0031	-0.37	0.9976	1.4 - 15.1	0.20	36
Chloride	0.9996	1.60	0.9998	40 - 202	0.74	34
Calcium	0.9857	0.06	0.9972	0.4 - 5.0	0.07	48

The linearity studies support the following reportable range.

Measuring Range Dialysate	Na: 40 - 200 mEq/L
	K: 1.7 - 15 mEq/L
	Cl: 50 - 200 mEq/L
	Ca: 0.3 - 5.5 mmol/L

(11) Summary of clinical tests - Whole blood, serum, plasma and urine were previously cleared (K082462).

Clinical testing was conducted to demonstrate the correlation of Diagnostics SMARTLYTE Analyzer to predicate devices operated by trained personnel. Dialysates were collected for testing on the SMARTLYTE and the predicate device, the Roche 9180. Some samples were spiked or diluted to fully span the claimed measuring ranges. The results are summarized below. Regression analysis show good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04.

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Dialysate Comparison SMARTLYTE versus AVL 9180 (K961458)

Parameter Slope		Intercept	R	Range	П	Styx
Sodium	1.0183	-2.52	0.9989	49 – 179	43	1.31
Potassium 0.9882		0.04	0.9996	1.5 - 14	56	0.08
Chloride	0.9825	2.86	0.9966	52 - 199	51	2.25
Calcium	1.0021	0.03	0.9956	0.25 - 4.5 - 43		0.08

The method comparison study supports correlation in the following reportable range.

Measuring Range Dialysate

Na: 40 - 205 mEq /L K: 1.7 - 11 mEq /L . Cl: 50 - 205 mEg /L Ca: 0.3 - 5.5 mmol/L

(12) Conclusions drawn from the clinical and non-clinical testing.

Analysis of the dialysate comparative measurements presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical trails demonstrates that the Diamond Diagnostics SMARTLYTE Electrolyte Analyzer (with Na , K , C , Ca*, Li ) is safe, effective and substantially equivalent to the predicate devices, AVL 9180 (K961248).

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Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, often associated with medicine and healthcare.

10903 New Hampshire Avenue Silver Spring, MD 20993

Diamond Diagnostics, Inc. c/o Kathy Cruz 333 Fiske St. Holliston, MA 01746

AUG 3 0 2012

K121040 Re:

Trade Name: SMARTLYTE Electrolyte Analyzer Regulation Number: 21 CFR §862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Codes: JGS, CEM, CGZ, JFP, JIH Dated: August 2, 2012 Received: August 3, 2012

Dear Kathy Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becally be clevice is substantially equivalent (for the referenced above and have determined the to regally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce pror to that have been reclassified in accordance with the provisions of Amendinents, or to de rious that nero a Act (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmene . Act (116) ... market the device, subject to the general approval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the restration, 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 (1 MA), it may be subject to back adamations (CFR), Parts 800 to 895. your device can be found in The 27, 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 mean that FDA nas made a determinaremilations administered by other Federal agencies. of the Act of ally I ederal statutes and reguirements, including, but not limited to: registration You must comply with an the Act 5 require.com Parts 801 and 809); medical device in and listing (21 CFN Part 807), labeling (21 CFR 803); and good reporting (reporting of medical device related an research as the regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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 (if known): K121040

Device Name: SMARTLYTE Electrolyte Analyzer

Indications For Use:

The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, potassium, chloride and calcium in dialysate samples.

The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, prediluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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.

The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood. plasma, serum, and dialysate. Calcium measurements are used in the diagnosis and treament of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

ifung Chan

Division Sign-Of Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121040

Pagel of |

Regulation Number and Section

§ 862.1600 Potassium test system.

(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.