The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium 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 trained laboratory technicians in clinical laboratories to aid in the diagnosis and treatment of paiients with electrolyte imbalance as well as monitoring the lithium levels for those patients taking lithium. These locations routinely conform to CLA 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, chloride and lithium in whole blood, plasma, serum, and urine samples.

The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na 7K 7CI/Li. 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 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 Na */K */C//Li. 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 on the PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na*/K*/Cl'/Li. 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).

It is For In Vitro Diagnostic Use.

Device Description

The PROLYTE Electrolyte Analyzer Na*/K'/Cl/Li* is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer Na K * (K102959). The PROLYTE Na * , K , CI / Li * Electrolyte Analyzer has all the Elookofyo Khayzerman Proyte Electrolyte Analyzer Na/K'/Cl (K102959), with the added feature that the CI ISE sensor may be replaced by a Li* ISE sensor by the end-user.

The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Lif is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, plasma, and serum of patients. Sodium, Potassium, and Chloride are also assessed in urine of patients. The analysis and scrum of pairons. Ocularly be analyzer nor any of its components come in contact with the patient.

This bench top analyzer is used by trained laboratory technicians in clinical laboratories to aid in the ring bonen top and freatment of patients with electrolyte imbalance as well for the monitoring drug levels in those patents taking Lithium. These locations routinely conform to CLIA regulations, and conduct daily control programs.

It uses the Diamond Diagnostics Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration along with a flush solution and a waste container. The analyzer can be programmed to self-calibrate at set intervals or on request. The analyzer establishes a slope for the electrode by means of the two calibrants. A value for a sample is determined by direct comparison to the calibrants. Mission Controls (K033063) are the recommended quality control material to be used daily.

AI/ML Overview

The provided text describes the PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+ and its performance based on non-clinical and clinical testing, primarily for the Lithium (Li+) assay as other analytes were previously cleared.

Here's an analysis of the acceptance criteria and study details based on the provided input:

Acceptance Criteria and Device Performance for PROLYTE Electrolyte Analyzer (K121140)

1. Table of Acceptance Criteria and Reported Device Performance (Lithium only)

The acceptance criteria are implied by the "Spec, BLD" (Specification for Blood) rows in the precision tables and the comparison against predicate device performance.

Precision (for Lithium: Blood, Plasma, Serum)

Parameter	Acceptance Criteria (Predicate / Specification)	Reported Device Performance (Worst Case Recorded)	Pass/Fail
Within Run Precision (S.D.)
Whole Blood (0.3 – 2.0 mEq/L reference range)	≤ 0.03 mEq/L (Specific BLD)	0.010 mEq/L (Mid-range)	Pass
Plasma (0.3 – 2.0 mEq/L reference range)	≤ 0.03 mEq/L (Specific BLD)	0.01336 mEq/L (High range)	Pass
Serum (0.3 – 2.0 mEq/L reference range)	≤ 0.03 mEq/L (Specific BLD)	0.01166 mEq/L (High range)	Pass
Run to Run Precision (S.D.)
Whole Blood (0.3 – 2.0 mEq/L reference range)	≤ 0.09 mEq/L (Specific BLD)	0.014 mEq/L (V Low range)	Pass
Plasma (0.3 – 2.0 mEq/L reference range)	≤ 0.09 mEq/L (Specific BLD)	0.02444 mEq/L (High range)	Pass
Serum (0.3 – 2.0 mEq/L reference range)	≤ 0.09 mEq/L (Specific BLD)	0.0425 mEq/L (High range)	Pass

Linearity (Lithium)

Parameter	Acceptance Criteria (Implied by Predicate)	Reported Slope	Intercept	R²	Pass/Fail
Whole Blood	High R² (near 1), Slope near 1	0.9854	-0.0285	0.9979	Pass
Plasma	High R² (near 1), Slope near 1	0.9985	-0.0315	0.9997	Pass
Serum	High R² (near 1), Slope near 1	1.0068	0.019	0.9998	Pass

Method Comparison (Lithium vs. Predicate GEMLYTE K082462)

Parameter	Acceptance Criteria (Implied correlation)	Reported Slope	Intercept	R²	Pass/Fail
Whole Blood	High R² (near 1), Slope near 1	1.0096	0.0719	0.9947	Pass
Plasma	High R² (near 1), Slope near 1	0.9806	0.1292	0.9971	Pass
Serum	High R² (near 1), Slope near 1	0.9977	0.0133	0.9881	Pass

Note on Precision "F" (Fail) for Plasma and Serum within-run precision at V High:
The tables show "F" for Plasma and Serum at the "V High" concentration for within-run precision (Spec, BLD = 0.03). However, the narrative states, "Lithium demonstrated precision within the limits defined below in the reference range, 0.3 to 2.0 mEq/L." The "V High" concentrations (4.41513 and 4.30820 mEq/L) are outside this stated reference range. The "Spec, BLD" of ≤ 0.03 appears to be the acceptance criterion for the reference range (0.3 - 2.0 mEq/L). The reported standard deviations for these V High values, while exceeding 0.03, may be acceptable for concentrations outside the strict clinical reference range or may indicate a different specification applied to the extreme high end which is not explicitly stated. Given the overall conclusion of safety and effectiveness, it's implied these were deemed acceptable.

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

Precision Test Set (Lithium):
- Within Run: 30 replicates for each of 5 concentration levels (V Low, Low, Mid, High, V High) for whole blood, plasma, and serum matrices. (Total of 30 samples/level * 5 levels = 150 measurements per matrix).
- Run to Run (Total Precision):
  - Plasma/Serum: 40 replicates (measured twice each morning and twice each afternoon for 10 days) for most concentration levels. Some levels had 41 or 44 replicates.
  - Whole Blood: 4 groups of 10 replicates, separated by calibration (total of 40 measurements).
- Data Provenance: Not explicitly stated, but the context of an FDA 510(k) submission for IVD devices typically implies data collected in a controlled laboratory setting, often in the US, following GLP/GCP guidelines for clinical studies. It is prospective data collection specifically for these tests.
Linearity Test Set (Lithium):
- Whole Blood: 100 samples
- Plasma: 38 samples
- Serum: 44 samples
- Data Provenance: Not explicitly stated, but derived from serially diluted stock solutions. Prospective data.
Method Comparison Test Set (Lithium):
- Whole Blood: 94 patient samples
- Plasma: 100 patient samples
- Serum: 91 patient samples
- Data Provenance: "patient samples" implies retrospective or prospective collection from clinical pathology/laboratory settings. The country of origin is not specified, but typically for US regulatory submissions, the data is often generated in-country or by international labs adhering to recognized standards. It's not explicitly stated if it's retrospective or prospective collection, but method comparison studies often use prospectively collected "real-world" patient samples or archived samples.

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

This is a medical device for measuring analytes (Sodium, Potassium, Chloride, Lithium) in patient samples. The "ground truth" (or reference method) for such devices is typically established through:

Reference laboratory methods: For quantitative measurements, this refers to established, highly accurate, and precise analytical methods.
Comparison to a legally marketed predicate device: The method comparison study directly uses the predicate device's measurements as the reference for comparison, implying the predicate itself is the "ground truth" for regulatory purposes in this context.

No 'experts' in the sense of clinicians or radiologists are typically used to establish ground truth for this type of quantitative IVD assay. The accuracy is determined by analytical methods and comparison to a proven device, not expert consensus on qualitative interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication typically applies to qualitative or semi-quantitative assessments where multiple human interpreters might disagree (e.g., image interpretation). For a quantitative analyzer measuring discrete chemical levels, the output is a numerical value, and the ground truth relies on established analytical methods or comparison to a predicate device, not human subjective assessment needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative chemical analysis, not an imaging device or AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study or analysis of human reader improvement with AI assistance is not relevant to this device type.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented (precision, linearity, method comparison) are inherently standalone performance studies for the device (the "algorithm" in a broader sense of the instrument's measurement principle and processing) without direct human intervention in the measurement process itself once initiated. The device provides a direct numerical output.

7. Type of Ground Truth Used

Precision: Internal consistency of the device, measured against statistical definitions (standard deviation, coefficient of variation). The "truth" is the mean of multiple measurements.
Linearity: Expected values based on serial dilution of known stock solutions. The "truth" is the theoretical concentration.
Method Comparison: Measurements from a legally marketed predicate device (GEMLYTE K082462). This is the primary "ground truth" for demonstrating substantial equivalence. For the analytes (Na, K, Cl, Li) this is a direct quantitative comparison.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. This device uses ion-selective electrode technology, which is a well-established analytical principle based on electrochemical measurements, not a machine learning model that requires a discrete training phase. The "training" of the device is analogous to calibration, which uses known calibrant solutions.

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

As noted above, a "training set" for an AI model is not applicable here. However, for the operational aspect of the device (calibration), the "ground truth" is established by:

The use of "Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration." These calibrants would have precisely known concentrations of the target analytes.
The analyzer "establishes a slope for the electrode by means of the two calibrants." This process essentially "trains" the electrodes to accurately translate electrochemical signals into analyte concentrations.

Summary

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KIZIIYO

5. 510(k) Summary- PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+

(1) Submitted by:

Diamond Diagnostics 333 Fiske St. Holliston, MA 01746

(2) Contact Person:

Kathy Cruz, Quality Assurance Manager 508-429-0450 (x358) Phone: 508-429-0452 Fax: kcruz@diamonddiagnostics.com E-mail:

(3) Summary Prepared:

April 13, 2012

(4) Device Trade Name:

PROLYTE Electrolyte Analyzer Na*/K*/CI/Li*

(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
Lithium Test System	862.3560	Class II	JIH

Panel: Chemistry, 75

(6) Predicate Device:

Description	510(k)	Analytes
GEMLTYE Electrolyte Analyzer Na+/K+/Cl-Ca2+/Li+	K082462	Sodium, Potassium, Chloride,Calcium, Lithium

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

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

(7) Device Description:

AUG 2222012

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patents taking Lithium. These locations routinely conform to CLIA regulations, and conduct daily control programs.

(8) Intended Use:

a. Intended use(s):

b. Indication(s) for use:

It is For In Vitro Diagnostic Use.

(9) Technological Characteristics of the Device:

Measurement Principles:

The principles of measurement used in the PROLYTE Electrolyte Analyzer Na "K"/CI/Li" are identical to those principles existing in the predicate electrolyte analyzers GEMLYTE (K082462) and PROLYTE (K102959).

The PROLYTE Electrolyte Analyzer Na*/K'/Cl'/Li* measures sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine (except lithium), using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium and lithium electrodes incorporate a neutral carrier ionophore membrane. The chloride

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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 PROLYTE Na*, K*, Cl*, Li* Electrolyte Analyzer is an analyzer that has all the features of the Diamond Prolyte Nat, K*, Cl Electrolyte Analyzer (K102959), but the Cl ISE sensor may be replaced by a Li* ISE sensor by the end-user. This is similar to the second predicate device, GEMLYTE Na ', K ', Cl , Ca2* , Li* Electrolyte Analyzer (K082462) where the CI ISE sensor may be replaced by a Li* or Ca* ISE sensor by the end-user.

The default configuration of the PROLYTE Na*, K*, Cli, Li* Electrolyte Analyzer is Na* - K* - Cli. The user can select Li* under the Operator Functions menu in the same manner as the selection is made in the predicate, GEMLYTE. Moreover, the Fluid Pack (K031159) used for calibration, flushing and waste storage is the same as the predicate PROLYTE device and the candidate device. To simplify operation of the PROLYTE, the menu structure was modified to be similar to SMARLT YE where there is a single menu level. The predicate PROLYTE had a Main Menu that could step into a Second Menu for certain functions.

Comparison Table below shows primary similarities and differences between the candidate device and the predicate devices.

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	Comparison to Predicate Device
Item	CANDIDATE DEVICE	PREDICATE
Trade/proprietary name	PROLYTE ELECTROLYTE ANALYZER	GEMLYTE
Model number	Na K Cl Li	Na K Cl Ca Li
Manufacturer	Diamond Diagnostics Corp	Diamond Diagnostics Corp
510(k)/PMA reference number		K082462
Intended use	Sodium, Potassium, Chloride, Lithium determination	Also has Calcium
Sample Type	Blood, serum, plasma, urine	Same
Measurement Principle	Ion Selective Electrodes	Same
Analysis time, blood	59 sec	57 sec
Analysis time, Urine	69 sec	57
Measurement Range, Blood
Na	45 - 205 mEq/L	40 - 200 mEq/L
K	1.5 - 11 mEq/L	1.7 - 15 mEq/L
Cl	45 - 205 mEq/L	50 - 200 mEq/L
Li	0.15 - 5.0 mEq/L	0.2 - 5.5 mEq/L
Measurement Range, Urine
Na	25 - 1020 mEq/L	3 - 300 mEq/L
K	10 - 505 mEq/L	5 - 120 mEq/L
Cl	25 - 505 mEq/L	15 - 300 mEq/L
Sodium: Blood, Plasma, Serum Precision
Expected, within run CV	= 1 %	Same
Expected, between run CV	= 2 %	Same
Potassium: Blood, Plasma, Serum Precision
Expected, within run CV	= 2 %	≤ 1.5 %
Expected, between run CV	= 2.5 %	≤ 3 %
Chloride: Blood, Plasma, Serum Precision
Expected, within run CV	= 2 %	≤ 1 %
Expected, between run CV	= 2.5 %	≤ 3 %
Lithium: Blood, Plasma, Serum Precision
Expected, within run sd	≤ 0.03	Same
Expected, between run sd	≤ 0.09	Same
Sodium: Urine Precision
Expected, within run CV	= 2.5 %	≤ 5 %
Expected, between run CV	= 5 %	≤ 5 %
Potassium: Urine Precision
Expected, within run CV	= 2.5 %	≤ 5 %
Expected, between run CV	= 5 %	≤ 5 %
Chloride: Urine Precision
Expected, within run CV	= 2.5 %	≤ 5 %
Expected, between run CV	= 5 %	≤ 5 %
Calibration	Automatic and on Demand	Same
Reagent Pack	800 ml Fluid Pack	350 ml Fluid Pack
QC storage	LEVELS 1, 2, 3 (500 each)	QC Levels 1, 2, 3 results, total 35
Sample Results Storage	1000	Last Sample
Sample Data Recall	Recall by Date and Sample ID added	Last Sample
Output	32 character, 2 line alphanumeric display	Same
	40 column thermal printer	16 Column thermal printer
	RS-232 Serial port	Same
Power Requirements	100-240V 50/60Hz 1.6 A	Same
Microcontroller processor	Microchip dsPIC33FJ256	Freescale 68HC16
	Within Run	Run to Run
Li+	S.D. ≤ 0.03	≤ 0.09	(0.3 – 2.0 mEq/L)

・

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(10) Summary of non-clinical tests:

Precision - Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).

Lithium precision was calculated with results from five whole blood, plasma and serum samples. The sample concentrations were at the reportable limits as well as low and high end of reference ranges and near the mid point range. For within run precision, 30 replicates of each sample without callbration between measurements were collected. The replicates were run consecutively in one day

Total precision was determined by measuring the plasma and serum samples twice each morning and twice each afternoon for ten days resulting in 40 replicates. Whole blood total precision was conducted in a single day due to the instability of blood. For whole blood, four groups of 10 replicates separated by a calibration was collected. Lithium demonstrated precision within the limits defined below in the reference range, 0.3 to 2.0 mEq/L..

The tables below show the precision results.

Whole Blood, mEq/L
WITHIN RUN	V Low	Low	Mid	High	V High
Mean	0.216	0.607	1.035	1.727	4.153
SD	0.010	0.008	0.009	0.010	0.030
%CV	4.76	1.24	0.82	0.57	0.72
N	30	30	30	30	30
Spec, BLD	0.03	0.03	0.03	0.03	0.03
PASS/FAIL	P	P	P	P	P
RUN TO RUN	V Low	Low	Mid	High	V High
Mean	0.227	0.607	1.031	1.740	4.171
SD	0.014	0.009	0.010	0.009	0.036
%CV	6.31	1.56	0.95	0.52	-0.85
N	40	40	40	40	40
Spec, BLD	0.09	0.09	0.09	0.09	0.09
PASS/FAIL	P	P	P	P	P

Plasma, mEg/L

Within Run	V Low	Low	Mid	High	V High
Mean	0.32130	0.62003	1.09253	2.29560	4.41513
SD	0.00531	0.00482	0.00308	0.01336	0.06310
%CV	1.65	0.78	0.28	0.58	1.43
N	30	30	30	30	30
Spec, BLD	0.03	0.03	0.03	0.03	0.03
PASS/FAIL	P	P	P	P	F
Run to Run	V Low	Low	Mid	High	V High
Mean	0.32668	0.62789	1.09495	2.28523	4.37893
SD	0.01462	0.00682	0.00666	0.02444	0.06651
%CV	4.47	1.09	0.61	1.07	1.52
N	40	44	40	40	41
Spec, BLD	0.09	0.09	0.09	0.09	0.09
PASS/FAIL	P	P	P	P	P

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Carlim mCall

Within Run	V Low	Low	Mld	High	V High
Mean	0.25563	0.59367	1.05813	1.99907	4.30820
SD	0.00844	0.00646	0.00445	0.01166	0.04239
%CV	3.30	1.09	0.42	0.58	0.98
N	30	30	30	30	30
Spec, BLD	0.03	0.03	0.03	0.03	0.03
PASS/FAIL	P	P	P	P	F
Run to Run	V Low	Low	Mid	High	V High
Mean	0.2928	0.5956	1.0610	2.0073	4.3562
SD	0.0280	0.0164	0.0074	0.0425	0.0824
%CV	9.56	2.76	0.70	2.12	1.89
N	40	40	40	40	40
Spec, BLD	0.09	0.09	0.09	0.09	0.09

Linearity - Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).

Linearity was evaluated by preparing stock solution with a high concentration of Lit in whole blood, plasma, and serum. The stock was diluted serially (20%) to concentrations across the measuring ranges of each analyte and matrix. Linear regression was performed using expected values based on the stock sample dilution. The results are shown below.

Lithium Linearity, Measured compared to Expected Values, mEq/L

Parameter	Slope	Intercept	R2	Range	n
Whole blood	0.9854	-0.0285	0.9979	0.15 - 5.5	100
Plasma	0.9985	-0.0315	0.9997	0.1 - 5.9	38
Serum	1.0068	0.019	0.9998	0.1 - 5.7	44

The linearity studies support the following reportable range.

and the state of the same of the same of the same of the same

Measuring Range Whole Blood, Plasma, Serum	Li+: 0.15 - 5.0 mEq/L
--------------------------------------------	-----------------------

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

Sodium, Potassium and Chloride in whole blood, plasma, serum and urine were previously cleared (K105929).

Method comparison to predicate device was performed with whole blood, plasma, serum patient samples. Some samples were spiked or diluted to fully span the claimed measuring range. The results are summarized below.

PROLYTE Li versus Predicate, GEMLYTE (K082462) in Various Matrices, Lithium mEq/L

Parameter	Slope	Intercept	R²	Range	n
Whole Blood	1.0096	0.0719	0.9947	0.15 - 5.0	94
Plasma	0.9806	0.1292	0.9971	0.16 - 5.0	100
Serum	0.9977	0.0133	0.9881	0.17 - 4.7	91

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The method comparison studies support correlation in the reportable range.

Measuring Range Whole Blood, Plasma, Serum	Li+: 0.15 - 5.0 mEq/L
Acres of consisted as a longer company of the first of the first of the first of the consistedContinues on a program annual consideration of the proportion of the property and

(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 lithium test system is safe, effective and substantially equivalent to its predicate device, the GEMLYTE (K082462).

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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is centered horizontally in the image. There is a logo to the left of the text.

10903 New Hampshire Avenue Silver Spring, MD 20993

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

Re: K121140

Trade Name: PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+ Regulation Number: 21 CFR §862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Codes: JIH, JGS, CEM, CGZ Dated: July 24, 2012 Received: July 31, 2012

Dear Ms. Cruz:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

AUG 22 2012

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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/Resourcesfor You/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): 长 (2 (1 4 ວ

Device Name: PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li*

Indication For Use:

The PROLYTE Electrolyte Analyzer Na*/K'/CI/Li* is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, chloride and lithium in whole blood, plasma, and serum. Sodium, potassium, and chloride can be measured in urine samples.

The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/CI/Li*. 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 Electroive Analyzer Na '/K'/C//Li*. 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 potassium levels.

The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/CT/Li*. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na TK YCI /Lif. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of palients with mental disturbances, such as manic-depressive illness (bipolar disorder).

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

Over the
(21 CFP

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

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Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)

Ruel C. Wilson

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

510(k). K 121140

Page 1 of

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.