Who is the manufacturer of SMARTLYTE ELECTROLYTE ANALYZER?

Diamond Diagnostics, Inc. filed the 510(k) submission for SMARTLYTE ELECTROLYTE ANALYZER (K121040).

What is the FDA product code for SMARTLYTE ELECTROLYTE ANALYZER?

CEM. It is classified under 21 CFR 862.1600 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for SMARTLYTE ELECTROLYTE ANALYZER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SMARTLYTE ELECTROLYTE ANALYZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SMARTLYTE ELECTROLYTE ANALYZER

K121040 · Diamond Diagnostics, Inc. · CEM · Aug 30, 2012 · Clinical Chemistry

Device Facts

Record ID	K121040
Device Name	SMARTLYTE ELECTROLYTE ANALYZER
Applicant	Diamond Diagnostics, Inc.
Product Code	CEM · Clinical Chemistry
Decision Date	Aug 30, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1600
Device Class	Class 2

Intended Use

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 Story

Automated, microprocessor-controlled electrolyte analyzer; uses ion-selective electrodes (ISE) to measure Na+, K+, Cl-, Ca++, and Li+ in clinical samples (blood, serum, plasma, urine, dialysate). Input: 95uL sample; Output: quantitative electrolyte concentrations displayed on alphanumeric screen, printed, or transmitted via RS-232/USB. Used in clinical settings by trained personnel. Features RFID-based reagent pack monitoring and expanded data storage. Self-calibrates every 4 hours or on-demand. Provides rapid diagnostic data to clinicians for managing electrolyte imbalances, renal/metabolic disorders, and lithium drug dosing.

Clinical Evidence

Bench testing only. Precision studies (n=30) and linearity studies performed on dialysate samples. Method comparison against AVL 9180 showed high correlation (r > 0.99) across reportable ranges for all analytes. No clinical prospective/retrospective trials on patients were required; performance established via analytical validation.

Technological Characteristics

Potentiometric ISE technology. Electrodes: glass tube (Na+), neutral carrier ionophore membranes (K+, Ca++), ionophore-bound substrate (Cl-). Reference: Ag/AgCl electrode. Connectivity: RS-232, USB, RFID. Power: 100-115V or 220V AC. Dimensions: 31.5x33.5x29.5 cm. Microprocessor-controlled.

Indications for Use

Indicated for patients requiring electrolyte monitoring (Na, K, Cl, Ca, Li) in whole blood, serum, plasma, urine, or dialysate. Used for diagnosis/treatment of renal, metabolic, cardiovascular disorders, and monitoring lithium therapy for mental disturbances. No specific age/gender contraindications listed.

Regulatory Classification

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.

Predicate Devices

AVL 9180 (K961458)

Reference Devices

GEMLYTE Electrolyte Analyzer (K082462)
Diamond Diagnostics Fluid Pack (K013850)
Mission controls (K033063)
IL Flame Photometer (K823480)
925 Chloridometer (K810615)

Related Devices

K961458 — AVL 9180 ELECTROLYTE ANALYZER · Avl Scientific Corp. · Jun 12, 1996
K972673 — AVL 9181 ELECTROLYTE ANALYZER · Avl Scientific Corp. · Aug 20, 1997
K102959 — PROLYTE ELECTROLYTE ANALYZER · Diamond Diagnostics, Inc. · Jan 14, 2011
K121140 — PROLYTE ELECTROLYTE ANALYZER · Diamond Diagnostics, Inc. · Aug 22, 2012
K082462 — GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ · Diamond Diagnostics, Inc. · Feb 6, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ ## (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: 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. AUG 3 0 2012 - {1}------------------------------------------------ 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). ## (8) Device Descriptions: 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. ## (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. {2}------------------------------------------------ | | 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, Lithium Determination | 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/L K 1.7 - 15 mEq/L Cl 50 - 200 mEq/L Ca 0.3 - 5 mmol/L Li 0.2 - 5.5 mEq/L | 40 - 205 mEq/L 1.5 - 15 mEq/L 50 - 200 mEq/L 0.2 - 5.0 mmol/L 0.1 - 6.0 mEq/L | | Measurement Range, Urine | Na 3 - 300 mEq/L K 5 - 120 mEq/L Cl 15 - 300 mEq/L | 1 - 300 mEq/L 4.5 - 120 mEq/L 1 - 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 ml Standard B 85 ml Standard C 85 ml Reference Solution 85 ml Waste bag R/W RFID Tag for monitoring individual fluid pack consumption | | | | | No RFID Tag | | Results Storage | Measurement results, 1000 QC Levels 1, 2, 3 results, each 500 Calibration Results, 5 | Measurement results, 1 QC Levels 1, 2, 3 results, total 35 Calibration Results, 1 | | Output | 32 character, 2 line alphanumeric display thermal printer RS-232 Serial port USB ports (2) RFID Board to R/W RFID Tag | Same Same Same | | Power | 100-115 - VAC 50-60 Hz, 0.8 A or | Same Same | | | 220-VAC 50/60 Hz, 0.4 A | Same | : 11 - 11 : ・ . . . ﺎ ・ {3}------------------------------------------------ ## 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 {4}------------------------------------------------ ## Reproducibility: | | | Blood, Plasma, Serum, Dialysate | | Kt | | | | |----------------------------------------------------------------------------------------------------------|-------|---------------------------------|--------------------------|-------------------------------|--------------------------------|-------------------------------|--| | Within Range (n=30) Between Run (10 days) | | Na C.V. ≤ 1% C.V. ≤ 2% | C.V. ≤ 1.5% C.V. ≤ 3% | Cl. C.V. ≤ 2% C.V. ≤ 3% | Ca** SD ≤ 0.02 SD < 0.06 | Lit SD < 0.03 SD < 0.09 | | | | Urine | | | | | | | | Within Range (n=30) | | Na* C.V. ≤ 5% | K C.V. ≤ 5% | Cl. C.V. ≤ 5% | | | | | | | Between Run (10 days) | C.V. ≤ 5% | C.V. ≤ 5% | C.V. ≤ 5% | | | | Analysis Time | | 57 seconds | | | | | | | Calibration Every 4 hours, on demand 2 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% | | | | | | {5}------------------------------------------------ | 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. {6}------------------------------------------------ # 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). {7}------------------------------------------------ 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). {8}------------------------------------------------ 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 {9}------------------------------------------------ # 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 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 treament 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). 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 |