K Number

Device Name

PROLYTE ELECTROLYTE ANALYZER

Manufacturer

DIAMOND DIAGNOSTICS, INC.

Date Cleared

2011-01-14

(101 days)

Product Code

JGS CEM CGZ

Regulation Number

862.1665

Intended Use

The PROLYTE is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer (K070104). The PROLYTE Electrolyte Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient. This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of palients with electrolyte imbalance. These locations routinely conform to CLIA requlations, and conduct daily quality control programs. The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, and chloride in whole blood, plasma, serum, and pre-diluted urine samples. The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE 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 PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. 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 PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For In Vitro Diagnostic Use

Device Description

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and pre-diluted urine samples. The PROLYTE analyzer is designed with the user in mind. It is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface ensures that the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer can be programmed to selfcalibrate using Mission Diagnostics Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) 033063) are the recommended quality control material to be used daily.

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Expedited Review

Predicate Devices

K070104

Reference Devices

K070104, 031159, 033063

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on microprocessor control and ion-selective electrodes, with no mention of AI or ML.

Therapeutic

No.
The device is an in-vitro diagnostic (IVD) device used for measuring electrolyte levels in body fluids to aid in diagnosis, not to provide therapy or directly treat a disease.

Diagnostic

Yes

Explanation: The "Intended Use" section explicitly states that the device is used "to aid in the diagnosis and treatment of patients with electrolyte imbalance" and that measurements obtained are used "in the diagnosis and treatment" of various listed conditions. The final line also states "For In Vitro Diagnostic Use".

SaMD (Software as a Medical Device)

The device description explicitly states it is an "automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes" and mentions hardware components like electrodes and fluid packs. This indicates it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use".
Nature of Analysis: The device analyzes samples (whole blood, serum, plasma, urine) in-vitro (outside of the living body) to measure levels of substances (Sodium, Potassium, Chloride).
Purpose of Analysis: The measurements are used to "aid in the diagnosis and treatment of patients with electrolyte imbalance" and to "monitor electrolyte balance in the diagnosis and treatment of" various diseases. This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
Clinical Laboratory Use: The device is intended for use in clinical laboratories by laboratory professionals and trained technicians, which is a typical setting for IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PROLYTE is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer (K070104).

The PROLYTE Electrolyte Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.

This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte imbalance. These locations routinely conform to CLIA regulations, and conduct daily quality control programs.

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, and chloride in whole blood, plasma, serum, and pre-diluted urine samples.

The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE 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 PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. 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 PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

For In Vitro Diagnostic Use.
Prescription Use X (21 CFR Part 801 Subpart D)

Product codes (comma separated list FDA assigned to the subject device)

JGS, CEM, CGZ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Used by laboratory trained technicians in clinical laboratories. These locations routinely conform to CLIA regulations, and conduct daily quality control programs.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Studies:

Study Type: Within-run precision and Total precision.
Sample Size: 30 replicates for within-run precision, 40 replicates for total precision per sample type and analyte.
Key Results (Within Run Imprecision):
- Whole Blood:
  - Na+: CV ~0.60% - 0.91%
  - K+: CV ~0.79% - 1.20%
  - Cl-: CV ~0.72% - 0.80%
- Plasma:
  - Na+: CV ~0.55% - 1.23%
  - K+: CV ~0.46% - 1.50%
  - Cl-: CV ~0.47% - 1.68%
- Serum:
  - Na+: CV ~0.50% - 0.85%
  - K+: CV ~0.66% - 1.41%
  - Cl-: CV ~0.67% - 1.65%
- Urine:
  - Na+: CV ~0.54% - 1.95%
  - K+: CV ~0.49% - 1.17%
  - Cl-: CV ~0.42% - 2.47%
Key Results (Total Imprecision):
- Whole Blood:
  - Na+: CV ~0.72% - 1.33%
  - K+: CV ~0.59% - 2.15%
  - Cl-: CV ~1.09% - 1.70%
- Plasma:
  - Na+: CV ~0.59% - 1.49%
  - K+: CV ~0.67% - 1.73%
  - Cl-: CV ~0.81% - 1.73%
- Serum:
  - Na+: CV ~0.76% - 1.36%
  - K+: CV ~0.80% - 1.66%
  - Cl-: CV ~0.83% - 1.80%
- Urine:
  - Na+: CV ~0.69% - 3.82%
  - K+: CV ~0.91% - 1.57%
  - Cl-: CV ~0.65% - 2.83%
    All demonstrated precision within defined limits.

Linearity Studies:

Study Type: Linearity evaluation using diluted stock solutions.
Sample Size: 27 to 54 samples per analyte/matrix combination.
Key Results: All R2 values were high (e.g., >0.99 for most, >0.9965 for all Serum analytes), indicating good linearity across the claimed measuring ranges.
- Whole Blood: R2 values ranged from 0.9973 to 0.9994.
- Plasma: R2 values ranged from 0.9985 to 0.9995.
- Serum: R2 values ranged from 0.9965 to 0.9997.
- Urine: R2 values ranged from 0.9991 to 0.9996.
  The linearity studies support the reportable ranges.

Clinical Tests (Method Comparison Studies):

Study Type: Method comparisons to predicate device.
Sample Size: 100 to 111 patient samples per matrix and analyte.
Key Results:
- Whole Blood Comparison: High R2 values (0.9844 to 0.9891) with slopes close to 1 and small intercepts, indicating good correlation with the predicate device.
- Plasma Comparison: High R2 values (0.9961 to 0.9971) with slopes close to 1 and small intercepts, indicating good correlation with the predicate device.
- Serum Comparison: High R2 values (0.9922 to 0.9950) with slopes close to 1 and small intercepts, indicating good correlation with the predicate device.
- Urine Comparison: High R2 values (0.9933 to 0.9995) with slopes close to 1 and small intercepts, indicating good correlation with the predicate device.
  The method comparison studies support correlation in the reportable range.
  All studies concluded that the PROLYTE Electrolyte Analyzer with new software is safe, effective and substantially equivalent to its predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found in these sections. Precision, Linearity, and Method Comparison (Slope, Intercept, R2) are reported.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070104

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Diamond Diagnostics 510(k) Submission for PROLYTE (New Software)

1. 510(k) Summary- PROL YTE Electrolyte Analyzer

(1) Submitted by:

Diamond Diagnostics 333 Fiske St. Holliston, MA 01746

(2) Contact Person:

Liann Voo, Director, QA and Scientific Development 508-429-0450 (x351) Phone: Fax: 508-429-0452 E-mail: lvoo@diamonddiagnostics.com

(3) Summary Prepared:

January 07, 2011

(4) Device Trade Name:

PROLYTE Electrolyte Analyzer Na*/K*/Cl

(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

Panel: Chemistry, 75

(6) Predicate Devices:

| Description | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) |
Analytes |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| PROLYTE Electrolyte Analyzer | K070104 | Potassium. Chloride
Sodium. |

Statement of Technology Characteristics of the Device Compared to Predicate Device:

Operating Principle	Predicate Device	PROLYTE
Potentiometric Na+, K+, Cl- Electrodes	K070104	SAME

(7) Device Description:

17 4 2011

(8) Intended Use:

a. Intended use(s):

The PROLYTE is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer (K070104).

This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of palients with electrolyte imbalance. These locations routinely conform to CLIA requlations, and conduct daily quality control programs.

b. Indication(s) for use:

For In Vitro Diagnostic Use

(9) Technological Characteristics of the Device:

Measurement Principles:

The principles of measurement used in the PROLYTE Electrolyte Analyzer are identical to those principles existing in the Predicate electrolyte analyzer K070104 PROLYTE.

The PROLYTE measures sodium, potassium and chloride in whole blood, serum, plasma, and urine, using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium incorporates a neutral carrier ionophore membrane. 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 Device:

The software for the PROLYTE has been rewritten. However, the functionality has remained primarily unchanged from the Predicate. The major change is in QC storage which allows for 3 control levels instead of 2 to be stored. In addition, the reportable range for the PROLYTE is wider for Na and K in Urine. Blood analysis time is slightly longer in the PROLYTE than the Predicate. Urine analysis time is shorter.

Comparison Table below shows primary similarities and differences.

SIMILARITIES
Item	Device	Predicate
Measurement Method	Ion Selective Electrodes	Same
Analytes Measured	Sodium, Potassium, Chloride	Same
Sample Matrix	Whole Blood, Plasma, Serum,
Urine	Same
Calibration	Automatic and On-Demand	Same
Measuring Range Whole Blood,
Plasma, Serum	Na: 45 - 205 mEq/L
K: 1.5 - 11 mEq/L
Cl: 45 - 205 mEq/L	Same
Measuring Range Urine	Cl: 25 - 505 mEq/L	Same

DIFFERENCES
Item	Device	Predicate
Measuring Range Urine	Na: 25 - 1020 mEq/L
K: 10 - 505 mEq/L	Na: 30 - 1020 mEq/L
K: 20 - 505 mEq/L
Blood Analysis Time	59 seconds	57 seconds
Urine Analysis Time	69 seconds	93 seconds
QC Storage	Low, Normal, High, 30 each	Normal, Abnormal, 20 each

(10) Summary of non-clinical tests:

Precision -

Within run precision was calculated with results from three whole blood, serum, plasma, and urine samples for each analyte. 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. Sodium, potassium and chloride all demonstrated precision within the limits defined below.

Serum/Blood	Urine (1:10 dilution)
Na+ C.V. ≤ 1%	C.V. ≤ 2.5%
K+ C.V. ≤ 2%	C.V. ≤ 2.5%
Cl- C.V. ≤ 2%	C.V. ≤ 2.5%

Typical Within Run Imprecision Results:

Whole Blood, mEq/L

	Na+	K+	Cl-
Mean	114.27	2.678	70.79
SD	0.69	0.021	0.57
%CV	0.60	0.79	0.80
N	30	30	30
Pass/Fail	P	P	P
	Na+	K+	Cl-
Mean	136.11	4.103	96.02
SD	0.80	0.032	0.62
%CV	0.58	0.78	0.64
N	30	30	30
Pass/Fail	P	P	P
	Na+	K+	Cl-
Mean	160.57	6.887	125.42
SD	1.47	0.083	0.91
%CV	0.91	1.20	0.72
N	30	30	30
Pass/Fail	P	P	P

Plasma, mEq/L

	Na+	K+	Cl-
Mean	93.07	2.376	61.27
SD	0.89	0.036	0.46
%CV	0.95	1.50	0.75
N	30	30	30
PASS/FAIL	P	P	P

	Na+	K+	Cl-
Mean	142.95	4.354	103.69
SD	0.78	0.037	0.59
%CV	0.55	0.85	0.57
N	32	32	32
PASS/FAIL	P	P	P
	Na+	K+	Cl-
Mean	165.80	6.622	123.57
SD	1.04	0.031	0.58
%CV	0.63	0.46	0.47
N	30	30	30
PASS/FAIL	P	P	P

Serum, mEq/L

	Na+	K+	CI-
Mean	120.10	3.026	70.30
SD	0.77	0.020	1.03
%CV	0.64	0.66	1.47
N	30	30	30
PASS/FAIL	P	P	P
	Na+	K+	Cl-
Mean	145.16	4.755	97.02
SD	0.86	0.034	0.65
%CV	0.59	0.70	0.67
N	30	30	30
PASS/FAIL	P	P	P
	Na+	K+	Cl-
Mean	163.21	6.536	118.80
SD	1.12	0.056	1.48
%CV	0.68	0.85	1.25
N	30	30	30
PASS/FAIL	P	P	P

Urine, mEq/L

	Na+	K+	CI-		Na+	K+	CI-		Na+	K+	CI-
Mean	33.26	31.967	52.89	Mean	121.83	78.548	184.34	Mean	202.84	112.432	274.38
SD	0.18	0.290	0.91	SD	0.83	0.384	1.15	SD	1.11	0.945	1.52
%CV	0.54	0.91	1.72	%CV	0.68	0.49	0.62	%CV	0.55	0.84	0.56
N	30	30	30	N	30	30	30	N	30	30	30
PASS/FAIL	P	P	P	PASS/FAIL	P	P	P	PASS/FAIL	P	P	P

Within Run Imprecision at Instrument Reporting Limits

Whole Blood, mEq/L

	Na+	K+	Cl⁻
Mean	53.15	1.678	47.90
SD	0.53	0.025	0.88
%CV	1.0	1.5	1.8
N	30	30	30
Pass/Fail	P	P	P

	Na+	K+	Cl-
Mean	193.33	10.363	196.26
SD	1.48	0.056	2.00
%CV	0.76	0.54	1.0
N	30	30	30
Pass/Fail	P	P	P

Plasma, mEq/L

	Na+	K+	Cl-
Mean	53.10	1.753	49.64
SD	0.65	0.025	0.83
%CV	1.23	1.41	1.68
N	30	30	30
Pass/Fail	P	P	P
	Na+	K+	Cl-
Mean	189.21	9.6407	197.15
SD	1.10	0.0934	1.26
%CV	0.58	0.97	0.64
N	30	30	30
Pass/Fail	P	P	P

Serum, mEq/L

	Na+	K+	Cl-
Mean	54.01	1.693	53.38
SD	0.46	0.024	0.88
%CV	0.85	1.41	1.65
N	30	30	30
Pass/Fail	P	P	P
	Na+	K+	Cl-
Mean	187.37	9.914	180.09
SD	0.94	0.070	1.42
%CV	0.50	0.71	0.79
N	30	30	30
Pass/Fall	P	P	P

Urine, mEq/L

	Na+	K+	Cl-
Mean	28.52	11.63	39.91
SD	0.56	0.14	0.99
%CV	1.95	1.17	2.47
N	30	30	30
Pass/Fail	P	P	P
	Na+	K+	Cl-
Mean	908.9	493.1	420.9
SD	6.4	3.1	1.8
%CV	0.70	0.62	0.42
N	30	30	30
Pass/Fail	P	P	P

Total precision was calculated with results from three whole blood, serum, plasma, and urine samples for each analyte. The samples concentrations were at the low and high end of reference ranges and near the mid point range. The serum, plasma and urine samples were measured twice each morning and twice each afternoon for ten consecutive days resulting in 40 replicates. Whole blood total precision was conducted on 2 different instruments with calibrations every consecutive replicates of 10 to total 40 replicates for each sample. Sodium, potassium and chloride all demonstrated total precision within the limits defined below.

	Serum/Blood	Urine (1:10 dilution)
Na+	C.V. ≤ 2%	C.V. ≤ 5%
K+	C.V. ≤ 2.5%	C.V. ≤ 5%
Cl-	C.V. ≤ 2.5%	C.V. ≤ 5%

Typical Total Imprecision Results:

Whole Blood, mEq/L

	Na+	K+	Cl-
Mean	113.69	2.649	71.24
SD	1.06	0.032	0.92
%CV	0.93	1.23	1.30
N	40	40	40
Pass/Fail	P	P	P
	Na+	K+	Cl-
Mean	136.36	4.103	96.51
SD	0.99	0.024	1.09
%CV	0.72	0.59	1.13
N	39	40	39
Pass/Fail	P	P	P
	Na+	K+	Cl-
Mean	161.22	6.924	126.41
SD	1.37	0.149	1.37
%CV	0.85	2.15	1.09
N	40	40	40
Pass/Fail	P	P	P

Plasma, mEq/L

	Na+	K+	Cl-		Na+	K+	Cl-		Na+	K+	Cl-
Mean	118.98	2.902	74.01	Mean	143.89	4.502	99.58	Mean	160.66	6.230	121.81
SD	0.85	0.050	0.93	SD	1.00	0.056	0.83	SD	0.94	0.092	0.99
%CV	0.71	1.73	1.25	%CV	0.70	1.25	0.83	%CV	0.59	1.48	0.81
N	40	40	40	N	40	40	40	N	40	40	40
PASS/FAIL	P	P	P	PASS/FAIL	P	P	P	PASS/FAIL	P	P	P

Serum, mEq/L

	Na+	K+	Cl-		Na+	K+	Cl-		Na+	K+	Cl-
Mean	119.04	2.970	69.02	Mean	144.03	4.732	100.13	Mean	160.71	6.502	119.93
SD	0.91	0.027	1.24	SD	1.26	0.038	0.83	SD	1.66	0.078	1.05
%CV	0.76	0.91	1.80	%CV	0.88	0.80	0.83	%CV	1.03	1.19	0.87
N	40	40	40	N	40	40	40	N	40	40	40
PASS/FAIL	P	P	P	PASS/FAIL	P	P	P	PASS/FAIL	P	P	P

Urine, mEq/L

	Na+	K+	Cl-
Mean	39.32	25.452	109.67
SD	1.50	0.398	2.77
%CV	3.82	1.57	2.53
N	40	40	40
PASS/FAIL	P	P	P
	Na+	K+	Cl-
Mean	116.87	79.485	183.51
SD	1.19	0.845	3.11
%CV	1.02	1.06	1.69
N	40	40	40
PASS/FAIL	P	P	P
	Na+	K+	Cl-
Mean	227.06	129.180	253.35
SD	3.35	1.178	4.45
%CV	1.48	0.91	1.76
N	40	40	40
PASS/FAIL	P	P	P

Total Imprecision at Instrument Reporting Limits

Whole Blood, mEq/L

	Na+	K+	Cl-		Na+	K+	Cl-
Mean	53.46	1.667	48.93	Mean	195.85	10.337	190.47
SD	0.71	0.030	0.83	SD	1.91	0.109	3.05
%CV	1.33	1.82	1.70	%CV	0.98	1.05	1.60
N	40	40	40	N	40	18	40
Pass/Fail	P	P	P	Pass/Fail	P	P	P

Plasma, mEq/L

	Na+	K+	Cl-		Na+	K+	Cl-
Mean	55.43	1.7795	50.07	Mean	189.28	9.709	198.86
SD	0.83	0.0297	0.87	SD	1.39	0.065	1.97
%CV	1.49	1.67	1.73	%CV	0.74	0.67	0.99
N	40	40	40	N	40	40	40
Pass/Fail	P	P	P	Pass/Fail	P	P	P

Serum, mEq/L

	Na+	K+	Cl-		Na+	K+	Cl-
Mean	55.26	1.700	53.56	Mean	187.10	9.9300	181.39
SD	0.75	0.028	0.93	SD	1.70	0.1050	1.68
%CV	1.36	1.66	1.73	%CV	0.91	1.06	0.93
N	40	40	40	N	40	40	40
Pass/Fail	P	P	P	Pass/Fail	P	P	P

Urine, mEq/L

	Na+	K+	Cl-		Na+	K+	Cl-
Mean	28.67	11.48	35.52	Mean	907.82	501.53	447.05
SD	0.66	0.17	1.01	SD	6.26	6.06	2.89
%CV	2.30	1.44	2.83	%CV	0.69	1.21	0.65
N	40	40	40	N	40	40	40
Pass/Fail	P	P	P	Pass/Fail	P	P	P

Linearity

Linearity was evaluated by preparing stock solutions with high concentrations of Na+, K+, and CI- in whole blood, plasma, serum, and urine. 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.

Whole blood Linearity, Measured compared to Expected Values

Parameter	Slope	Intercept	R2	Range	n
Sodium	1.0050	-3.8	0.9993	23 - 204	42
Potassium	1.0112	-0.24	0.9994	0.7 - 11.6	36
Chloride	1.0005	3.4	0.9973	33 - 211	42

Plasma Linearity, Measured compared to Expected Values

Parameter	Slope	Intercept	R2	Range	n
Sodium	0.9806	1.666	0.9993	30 - 205	42
Potassium	0.999	0.0555	0.9995	0.9 - 11.2	54
Chloride	0.9777	1.555	0.9985	31 - 209	42

Serum Linearity, Measured Concentration compared to Expected Values

Parameter	Slope	Intercept	R²	Range	n
Sodium	1.0021	0.3748	0.9997	20 - 219	33
Potassium	0.9989	0.0184	0.9995	1.3 - 13.1	33
Chloride	1.0264	-1.0423	0.9965	15 - 238	27

Urine, Measured Concentration compared to Expected Values

Parameter	Slope	Intercept	R2	Range	n
Sodium	1.0002	-2.1049	0.9996	16 - 1085	40
Potassium	1.0082	3.1433	0.9991	9 - 547	36
Chloride	0.9860	1.965	0.9991	22 - 504	34

The linearity studies support the following reportable range.

| Measuring Range Whole Blood,

Plasma, Serum	Na: 45 - 205 mEq/L
	K: 1.5 - 11 mEq/L
	Cl: 45 - 205 mEq/L
Measuring Range Urine	Na: 20 - 1020 mEq/L
	K: 10 - 505 mEq/L
	Cl: 25 - 505 mEq/L

(11) Summary of clinical tests submitted with the pre-market notification for the device.

Method comparisons to predicate device were performed with whole blood, plasma, serum and urine patient samples. A small number of samples were spiked or diluted to fully span the claimed measuring ranges. The results are summarized below.

Whole Blood Comparison, New PROLYTE versus Predicate, Original PROLYTE (K070104)

Parameter	Slope	Intercept	R2	Range	n
Sodium	1.0054	-2.9043	0.9875	48 - 205	110
Potassium	1.0095	-0.0675	0.9891	1.59 - 10.2	111
Chloride	0.9987	-2.1711	0.9844	45 - 203	108

Plasma Comparison of New PROLYTE and Predicate, Original PROLYTE (K070104)

Parameter	Slope	Intercept	R2	Range	n
Sodium	1.0243	-4.1003	0.9971	49 - 205	101
Potassium	0.9875	0.1004	0.9961	1.5 - 11.0	104
Chloride	1.0176	-7.9389	0.9965	45 - 204	101

Serum Comparison, of New PROLYTE and Predicate, Original PROLYTE (K170104)

Parameter	Slope	Intercept	R2	Range	n
Sodium	1.0119	-4.2748	0.9936	46 - 204	103
Potassium	0.9800	0.106	0.9950	1.5 - 10.8	100
Chloride	1.0144	-4.8408	0.9922	49 - 203	106

Urine Comparison, of New PROLYTE and Predicate, Original PROLYTE (K070104)

Parameter	Slope	Intercept	R2	Range	n
Sodium	0.9798	4.5946	0.9995	25 - 1020	102
Potassium	0.9879	0.0762	0.9991	11 - 499	105
Chloride	1.0179	-1.809	0.9933	26 - 504	101

The method comparison studies support correlation in the reportable range.

| Measuring Range Whole Blood,

Plasma, Serum	Na: 45 - 205 mEq/L
	K: 1.5 - 11 mEq/L
	Cl: 45 - 205 mEq/L
Measuring Range Urine	Na: 25 - 1020 mEq/L
	K: 10 - 505 mEq/L
	Cl: 25 - 505 mEq/L

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

Analysis of the comparative measurement 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 PROLYTE Electrolyte Analyzer with new software is safe, effective and substantially equivalent to its predicate device, the original PROLYTE (K070104).

Image /page/7/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Diamond Diagnostic, Inc. c/o Liann Voo Regulatory Affairs Specialist 333 Fiske Street Holliston, MA 01746

K102959 Re:

Trade Name: Prolyte Electrolyte Analyzer Regulation Number: 21 CFR §862.1665 Regulation Name: Sodium Test System. Regulatory Class: Class II Product Codes: JGS, CEM, CGZ Dated: December 23, 2010 Received: December 23, 2010

JAN 1 4 201

Dear Liann Voo:

We have reviewed your Section 510(k) premarket notification of intent to market the We liave levice your Sector 310(t) promised the device is substantially equivalent (for device felefenecod above and have actore) to legally marketed predicate devices
the indications for use stated in the enclosure) to legally marketed predicate of the the multations for use stated in the viace in the enactment date of the marketed in mersiale commerce prior to may 2016 to have been reclassified in accordance Medical Device Amendinents, of to devices management Act (Act (Act) that do not require
with the provisions of the Federal Food, Drug, and Cosmetic Act (Accefere, morket the with the provisions of the Federal Food, Bruggest A. You may, therefore, market the approval of a premarket approval upprovalissions of the Act. The general controls device, subject to the general controls pro connual registration, listing of devices, and provisions of the Act merded requirements on prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (300 additional controls. Existing major regulations (CE (PMA), it may be subject to such additional connects. Encludes Regulations (CFR), Parts
affecting your device can be found in ' like for consements concerners concerning you affecting your device can be round in This 22, 80 and 11 and 11 and 11 and 11 and device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does Please be advised that FDA > Issuance of a sacterming the complies with other not mean that FDA has made a determinations and regulations administered by other
requirements of the Act or any Federal statutes and regulations and not requirements of the Act of ally Proclar statute Act 3 requirements, including, but not
Federal agencies. You must comply with all the Act ' S requirements 801 and Federal agencies. You must compry with and 007); labeling (21 CFR Parts 801 and limited to: registration and ilsting (21 CF it an ocal device-related adverse events) (21
809); medical device reporting (reporting of medical device as sortorial in the qual 809); medical device reporting (cporting or mouter as set forth in the quality
CFR 803); and good manufacturing practice requirements as set forth in the quality
CFR 803); an systems (QS) regulation (21 CFR Part 820).

මෙම ප්‍රධාන ක්‍රි.

Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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 tollofire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

4. Indications for Use

510 (k) Number (if known):

Device Name: PROLYTE Electrolyte Analyzer

Indication For Use:

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potessium, and chloride undryzer which unders in the electived unine samples.

The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the horme 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), dehydrate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

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

Prescription Use × (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)

Richard Stone, D.D.S.

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

510(k) K102959