The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of pH, sodium, potassium, ionized calcium, and chloride in samples of whole blood, serum, plasma and aqueous controls in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

Device Description

The OPTI LION Electrolyte Analyzer is a small [4.7 x 14.2 x 9.1 inches, 10 pounds}, microprocessor-based instrument using optical fluorescence for the measurement of pH, sodium, potassium, ionized calcium, and chloride and utilizes a graphical touch screen user interface.

The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.

AI/ML Overview

The Osmetech OPTI LION Electrolyte Analyzer is a medical device intended for the measurement of pH, sodium, potassium, ionized calcium, and chloride in whole blood, serum, plasma, and aqueous controls. The following information details the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for each analyte. Instead, it refers to the "medically allowable errors as defined in CLIA'88 performance standards" as the benchmark for comparison. The study's conclusion is that the device's performance is acceptable against these standards.

Without specific numerical acceptance criteria from the document, we can infer the performance metrics reported as evidence of meeting an unspecified acceptable level based on CLIA'88 standards.

Analyte	Acceptance Criteria (Implied by CLIA'88 Standards)	Reported Device Performance (Systematic Differences and 95% CIs)
pH	Systematic differences and 95% CIs < Medically allowable errors (CLIA'88)	"lower than the medically allowable errors as defined in CLIA'88 performance standards"
Sodium	Systematic differences and 95% CIs < Medically allowable errors (CLIA'88)	"lower than the medically allowable errors as defined in CLIA'88 performance standards"
Potassium	Systematic differences and 95% CIs < Medically allowable errors (CLIA'88)	"lower than the medically allowable errors as defined in CLIA'88 performance standards"
Ionized Calcium	Systematic differences and 95% CIs < Medically allowable errors (CLIA'88)	"lower than the medically allowable errors as defined in CLIA'88 performance standards"
Chloride	Systematic differences and 95% CIs < Medically allowable errors (CLIA'88)	"lower than the medically allowable errors as defined in CLIA'88 performance standards"

2. Sample Size for the Test Set and Data Provenance

The document states: "Specimens analyzed in these tests were remnant from patient specimens of both whole blood and plasma or serum collected for routine analysis on existing instrumentation." This indicates the data provenance is retrospective, using pre-existing patient samples. The country of origin of the data is not specified, but the applicant company is based in Roswell, GA, USA.

The exact sample size for the test set is not explicitly stated in the provided text.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the performance of the OPTI LION Electrolyte Analyzer was correlated against "predicate devices" in a clinical setting. This implies the "ground truth" was established by measurements from these predicate devices.

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned. The comparison was made against predicate devices, which likely involved direct comparison of numerical results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study focused on comparing the device's performance against predicate devices, not on human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The "clinical testing was conducted to demonstrate the correlation of Osmetech OPTI LION Electrolyte Analyzer to predicate devices." This implies that the device (algorithm only, as it's an automated analyzer) was run on samples and its results were compared to those of existing predicate devices. The operation by "personnel minimally qualified to perform and report these results" indicates a human-in-the-loop for operation, but the performance being assessed is that of the analyzer itself.

7. The Type of Ground Truth Used

The ground truth used was established by measurements obtained from predicate devices. The document states, "Clinical testing was conducted to demonstrate the correlation of Osmetech OPTI LION Electrolyte Analyzer to predicate devices in a clinical setting." The "predicted systematic differences and their 95% confidence intervals between the OPTI LION and the predicated devices" were then compared to CLIA'88 performance standards.

8. The Sample Size for the Training Set

The document focuses on the validation of the device and does not provide information about a "training set" in the context of machine learning or AI models. This device is an analyzer that uses optical fluorescence and factory-calibrated cassettes, rather than an AI model that undergoes a training phase with a specific dataset. Therefore, the concept of a training set as typically understood for AI algorithms does not apply here, and no sample size for a training set is provided.

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

Given that the device is an analyzer based on optical fluorescence and factory-calibrated cassettes, it does not have a "training set" in the AI sense. Its calibration is performed during manufacturing, and each cassette contains bar-coded calibration information.

The description of calibration states: "Each lot of OPTI LION cassettes is calibrated during the manufacturing process... The OPTI LION system uses a proprietary dry calibration process... This dry-to-wet (mid-physiologic) relationship is stable and consistent for all sensors in a lot, and is characterized and bar-coded at the factory. In addition, the sensor's wet response curve of the fluorescent intensity versus analyte level is factory-characterized and bar-coded."

Therefore, the "ground truth" for the device's operational parameters (akin to a training phase in AI) is established through factory characterization and calibration based on known concentrations of analytes and the relationship between dry and wet fluorescent intensities. This is an engineered calibration rather than a data-driven training process with human-established ground truth.

Summary

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SEP 29 2005
K052027

Osmetech Inc.

Critical Care Division 235 Hembree Park Drive Roswell, GA 30076 USA Tel: +1 770 510 4444 +1 800 490 OPTI Fax: +1 770 510 4445

510(k) Summary

(a) (1) Submitter's name, address
Osmetech Inc. 235 Hembree Park Drive Roswell, GA 30076

Date of preparation of this summary:

Device trade or proprietary name: (2)

Contact Person Daniel R. McMinn Vice President, Operations 770.510.4444 x 4573

25 July 2005

OPTI LION Electrolyte Analyzer

Device common or usual name or classification name

pH and Electrolyte analyzer

CLASSIFICATIONProduct Nomenclature	ClassificationNumber	Class	Panel
ELECTRODE, BLOOD PH	75 CHL	II	CHEMISTRY
ELECTRODE, ION SPECIFIC, SODIUM	75 JGS	II	CHEMISTRY
ELECTRODE, ION SPECIFIC,POTASSIUM	75 CEM	II	CHEMISTRY
ELECTRODE, ION SPECIFIC, IONIZEDCALCIUM	75 JFP	II	CHEMISTRY
ELECTRODE, ION SPECIFIC, CHLORIDE	75 CGZ	II	CHEMISTRY

Substantial Equivalence (3)

The Osmetech OPTI LION Electrolyte Analyzer is substantially equivalent in finetion, safety and efficacy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: OPTI CCA 1K974784, K984299, and K852473], Roche OMNI [K945915, K990092], electrolyte analyzers such as AVL 995 [K895317] and AVI. 9180 [972763] and electric to the analyzer such as Roche Diagnostics Cobas Integra [K951595]. The OPTI LION is modified design of the OPTI Critical Care Analyzer [K974784, OF IT LION 15 11:54473] to allow measurement of only electrolytes and pH. A 1970 1277 and froatures between the Osmetech OPTI LION Electrolyte Analyzer and a number of the above listed devices is provided under the tab, Predicate Devices.

Description of the new device (4)

The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe

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into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.

Intended use of the device (5)

Technological characteristics of the device (6)

Principles of Measurement

The OPTI LION uses fluorescence optode to measure the intensity of light emitted from fluorescent dyes exposed to a specific analyte. The principle of measurement is similar to that used in OPTI CCA [K974784, K984299, and K852473]. The concentration of the analyte is determined by the calculation of the different in fluorescence measured at a defined calibration point and that measured with the unknown concentration of analyte.

Calibration

Each lot of OPTI LION cassettes is calibrated during the manufacturing process. Every cassette package has a barcode label containing this calibration information as well as its lot number and expiration date.

The OPTI LION system uses a proprietary dry calibration process based on the simple well-defined relationship of fluorescent intensity in the sensor's dry state to that in the sensor's mid-physiologic wet state, that is, the fluorescent intensity at mid-physiologic analyte levels. This dry-to-wet (mid-physiologic) relationship is stable and consistent for all sensors in a lot, and is characterized and bar-coded at the factory. In addition, the sensor's wet response curve of the fluorescent intensity versus analyte level is factory-characterized and bar-coded; similar to the proven method employed in the OPTI CCA analyzer.

Prior to running a sample, the cassette's bar code is read into the analyzer by 'swiping' the cassette package through a conveniently located bar code reader. The cassette is then installed and a calibration is performed. In addition, an optical zero point calibration of all optical channels is performed.

During the calibration and measurement processes, diagnostic tests are automatically performed to assure correct operation of the instrument and measurement of the cassette. These tests include automatic checks of the cassette for packaging integrity, proper cassette temperature control, and proper equilibration behavior of the sensors during calibration and measurement,

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automatic detection of bubbles and short sample during aspiration, automatic detection of dirty optics.

(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Performance Standards

The Osmetech OPTI LION Electrolyte Analyzer has been tested and found to comply with EN61010-1, FCC Class B, EN55022, EN61000-3-2, EN61000-3-3, and EN61326-1.

Precision।

The precision study was carried out following the experimental protocol recommended in the NCCLS guideline EP5-A, volume 19, Number 2 (1999). Typical Within-Run (Swr), Between-Day (Sdd) and Total (ST) precision were dctermined from two runs per day over 20 days on two OPTI LION instruments in simulated low- and high-use tests using three levels of aqueous quality control solution.

Linearity2

The precision study was carried out following the polynomial method recommended in the NCCLS guideline EP6-A, volume 23, Number 16 (2003). Wherever possible, linearity for the OPTI LION measurement has been established against reference materials or methods. Linearity for pH of plasma and whole blood are established by measurement of plasma and whole specimens which were tonometered to seven pH levels with various CO2 values, and measured on an AVL 995 and AVL 9181 pH/Blood Gas Analyzer standardized to N.J.S.T. traceable pH buffers, and on OPTI LION Analyzers.

Interferences3

Extensive testing for potential interferents has been carried out for OPTI CCA 510(k) interference study and has identified interferents which can affect the performance of the sodium, potassium, calcium, chloride and pH sensors in OPTI LION. Since the dry calibration is not affected by the interferent and the wet fluorophore is the same, we do not expect new sensitivities. Representative interference substances were evaluated following the NCCLS guideline.

1 NCCLS Approved Guideline, EPS-A, volume 19, Number 2, 1999: Evaluation of Precision Performance of Clinical chemistry Devices.

2 NCCLS Approved Guideline, EP6-A, volume 23, Number 16, 2003: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach.

3 NCCLS Approved Guideline, EP7-A, volume 22, Number 27, 2002: Interference Testing in Clinical Chemistrv.

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(b) (2) Summary of clinical tests submitted with the premarket notification for the device 4.

Clinical testing was conducted to demonstrate the correlation of Osmetech OPTI LION Electrolyte Analyzer to predicate devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed in these tests were remnant from patient specimens of both whole blood and plasma or serum collected for routine analysis on existing instrumentation.

In all evaluations, the predicted systematic differences and their 95% confidence intervals between the OPTI LION and the predicated devices for each test at medical decision levels are lower than the medically allowable errors as defined in CLIA'88 performance standards'

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

Analysis of the method comparison data collected during clinical trials for this device presented in the 510(k), together with the linearity and precision data collected during non-clinical trials demonstrates that the Osmetech OPTI LION is safe, effective, and equivalent to those predicate devices to which it is compared.

4 NCCLS Approved Guideline-Second Edition, EP9-A2, volume 22, Number 19, 2002: Method Comparison and Bias Estimation Using Patient Samples.

S Clinical Laboratory Improvements Amendments of 1988. Final Rule. Laboratory Requirements. Federal Register, February 28, 57:7002-7288, 1992.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

SEP 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Daniel R. McMinn Vice President, Opcrations Osmetech, Inc. 235 Hembree Park Drive Roswell, GA 30076

K052027 Re: R052027
Trade/Device Name: Osmetech OPI LION Electrolyte Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, JGS, CEM, JFP, CGZ, JJE Dated: July 25, 2005 Received: July 27, 2005

Dear Mr. McMinn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave tevenced 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 for use stated in the encrosure) to regarly and date of the Medical Device Amendments, or to conninered phor to they 20, 2017 11:57 accordance with the provisions of the Federal Food, DNI, C de vices mat have been require approval of a premarket approval application (PMA). and Costine Ace (71ct) that the device, subject to the general controls provisions of the Act. The 1 ou may, merciore, market the act include requirements for annual registration, listing of general controls provided on the practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device It may be subject to suen additional controllations (CFR), Parts 800 to 895. In addition, FDA can be found in The 21, Secoments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease oe advised that 1197 wation that your device complies with other requirements of the Act that I Dr has brade a acted regulations administered by other Federal agencies. You must of any I cach statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice errer 807), laboring in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) r ins letter wif anow you as ough finding of substantial equivalence of your device to a legally premarrer notification: " " results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of questions on the promotection and Safety at (240) 276-0484. Also, please note the Vitto Diagnostic DoMo Eranian by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other getarers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology 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): K052027

Osmetech OPTI LION Electrolyte Analyzer Device Name:

The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the The Osmeteri Of TFEFST Elossium, chloride, ionized calcium and pH in measurement of Southin, potacelard, plasma as appropriate in either a traditional samples of whole blocal or point-of-care locations by personnel minimally qualified to perform and report these results.

For Professional Use Only For In Vitro Diagnostic Use

Indications for Use

Sodium

Sodium is the major cation of extracellular fluid. Its primary functions in the body Soulum is the major oation or extire pressure and acid-base balance and to are to chemically maintain ochnolons at the cell membrane level by transmit nerve impaloos. Os and wetween different cell membranes causing the creating an cloothour potontial and neuromuscular excitability to be maintained. transmission of herve impalses une neations as a cofactor. The body Soundmiss involved in oche sintain a total base content, and only slight changes are found even under pathologic conditions.

Low sodium values, hyponatremia, usually reflect a relative excess of body water Eow sodium values, nypondi.org. Reduced sodium levels may be associated rather than a low total board com losses due to vomiting or diarrhea with adequate water and inadequate salt replacement, diuretics abuse, or salt-losing water and madequato out. replasses, metabolic acidosis; adreocortical insufficiency; ncphropatity, obmourolasia; dilution type due to edema, cardiac failure, hepatic failure; and hypothyroidism.

Elevated sodium values, hypernatremia, are associated with conditions with Lievated Socialt Value, 77) Por through profuse sweating, prolonged hyperpnea, watch 1635 in 0x0000 or diabetes insipidus or diabetic acidosis; increased severs vomm. conservation in hyperaldosteronism, Cushing's syndrome; ichal soulum consottake because of coma or hypothalamic diseases; dehydration; or excessive saline therapy.

The sodium value obtained may be used in the diagnosis or monitoring of all The Soundm Value obtainou may a, infusion therapies, vomiting, diarrhea, burns,

CA
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heart and kidney insufficiencies, central or renal diabetes insipidus, endocrine heart and kidney insumelors, contributions, cortex insufficiency of the adrenal gland or other diseases involving electrolyte imbalance.

Potassium

Potassium is the major cation in the intracellular fluid and functions as the Potassium is the major odtorning the inety percent of potassium is concentrated primaly buttlin the ocil leom through this your with the blood. Potassium within the cent, and damaged oolle rolose pollows function, and helps maintain acid-base balance and osmotic pressure.

Elevated potassium levels, hyperkalemia, can be found in oligouria, anemia, Lievated potassium lovels, itype due to nephritis or shock, metabolic or unnary obstruction, forfal fallar acidosis with the K*/H* exchange and respiratory acloosis, ronal tabalar aller and and the found in nemolysis of the blood. Eow potassium through diarrhea or vomiting, inadequate intake of excessive loss of potassian through and increased secretion of aldosterone. potassium, malaborption, or may cause changes in muscle irritability, respiration and myocardial function.

The potassium value obtained may be used to monitor electrolyte imbalance in The potassium value obtained infusion therapies, shock, heart or circulatory the diagnoois and trose imbalance, therapy with diuretics, all kinds of kidney illsumclerly, and buoe imbalando, includion of adrenal cortex and other diseases involving electrolyte imbalance.

Chloride

Chloride is an anion that exists predominantly in extracellular spaces. It Onionde 15 an anion through its influence on osmotic pressure. It is also manitatio oslidial integrity acid-base balance and water balance. In metabolic significant in monitoring and rise in chloride concentration when the bicarbonate concentration drops.

Decreased levels are found in severe vomiting, severe diarrhea, ulcerative colitis, Decreased levolo are role burns, heat exhaustion, diabetic acidosis, Addison's disease, fever and acute infections such as pneumonia.

Increased levels are found in dehydration, Cushing's syndrome, hyperventilation, eclampsia, anemia and cardiac decompensation.

Ionized Calcium

Calcium in blood is distributed as free calcium ions (50%) bound to protein, Oalcium in blood is alsthbattly bound to anions such as bicarbonate, citrate, phosphate and lactate. However, only ionized calcium can be sed by the body

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Division of Clinical Laboratory Devices 017027 510(k) Number

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in such vital processes as muscular contraction, cardiac function, transmission of
and the contraction of the CDTLLCON measures the innized portion in such vital processes as muscular confiraction, barneasures the ionized portion
nerve impulses and blood clotting. The OPTI LION measures the ionized portion nerve inipulses and blood oloting. The ouch as pancreatitis and of the total calcium. In cenain disorders outh as pants of the most than total calcium.

earning.
Elevated calcium, hypercalcemia, is found in patients with increased intestinal Elevated calcium, frypercationnia, is round is round no many learned renal absorption, incleased mobilization from bono (sesses). Hypercalcemia may
elimination, hyperparathyroidism and Addison's disease. Hypercalcemia m elimination, hyperparatifyroidism and Addiocire also soloments may
also be present in various types of malignancy, and calcium may ho elightly also be present in valious types of manghanoy, and sed calcium may be slightly serve as blochemical markers. In general, millions were about equal more sensitive, elther formzed of total salarin malignancy. Hypercalcemia occurs of utility in the delection of occurring in if its in acid-base regulation and losses of
critically ill patients with abnormalities in acid-base regulation and forms critically in patients with abriomaliation in acla base rogby ionized calcium measurements.

by reased calcium, hypocalcemia, is found in patients with decreased intestinal Decreased Calcium, fiypocalcemia, is found list in of Calcium in the absorption, increased renarelinination, increases or binding to citrate, and hypoparathyroidism.

Patients with renal disease caused by glomular failure often have altered Patients with reflat ulsease caused by glomain, magnesium and pH. Since these concentrations of Calcium, phoophate, albuming on 5
conditions tend to change ionized calcium independently of total catches in sepal conditions tend to change form20d calcialin monitoring calcium status in renal disease.

lonized calcium is important for diagnosis or monitoring of: hypertension forlized Calcian is important for alagricele costs on anutrition, kidney stones, multiple myeloma and diabetes mellitus.

lonized calcium may be reported either as the actual ionized calcium, referred to forlized calcium may be reported onized calcium, to a standard pH at
actual pH of the patients, or as normalized ionized calcium, to a standard hypi actual pH of the patients, or as nonnalized formation is influenced by pH 7.40. pr 7.40. The binding of odiolarily specimens should be analyzed at the pH of the patient's blood.

For more detailed information about the preanalytical variables affecting ionized For more detailed information about the production of NCCLS document C31calcium, please refer to the most carrent sales .
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling.

The pH value is an indicator of the balance between the buffer (blood), renal The pri value is an indicator of the balance of the most tightly controlled (kidney) and respiratory (fung) oyotems, and one only values are generally classified as:

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primary bicarbonate deficit metabolic acidosis .
primary bioarbonate excess metabolic alkalosis . respiratory acidosis
· primary hypoventilation
respiratory alkalosis · primary hyperventilation

An increase in blood, serum or plasma pH, alkalemia, may be due to increased An increase in blood, serum or plasma pri, akultima, any any increased plasma bloarbona.
elimination of CO2 due to hyperventilation.

ellimination of o Dead A decrease of pH value, academia, in broad, or an elected of H-ions in
an increased formation of organic acids, an increased excretion of H-ions in an increased formation of organic and intelessed as in salicylate poisoning
certain renal disorders, an increased acid intercoult of a decreased certain renal disorders, an increased and intires stant of a decreased
or loss of alkaline body fluids. Respiratory acidosis is the result of a decreased or loss of alkaline body hulds. Respiratory address of pulmonary edema, airway
alveolar ventilation and may be acute, as the result of obstructive or alveolar vehilation and may be acute, as the result of .
obstruction or medication, or maybe be chronic, as the result of obstructive or restrictive respiratory diseases.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

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

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Office of In Vitro Diagnostic Device Office of Safety

4/05/2027
510(k)

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.