← Product Code [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA) · K070704

# TRILOGY ANALYZER (K070704)

_Drew Scientific, Inc. · CGA · Jul 13, 2007 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K070704

## Device Facts

- **Applicant:** Drew Scientific, Inc.
- **Product Code:** [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA.md)
- **Decision Date:** Jul 13, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Pediatric

## Indications for Use

TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is an open system intended for clinical use in a professional setting for use with various chemistry assays that may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. TRILOGY is intended for the quantitative determination of glucose, creatinine and urea nitrogen in serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. TRILOGY includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium, and chloride in serum and urine. These measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.

## Device Story

TRILOGY Analyzer is a fully automated, discrete, software-driven, multi-purpose clinical chemistry analyzer. It processes serum and urine samples using photometric and potentiometric (ISE) methods. Input: samples loaded into a refrigerated carousel; identified via integrated barcode scanner. Transformation: liquid distribution module (small/large probes) aspirates/dispenses samples and reagents into 96-well microplates; optical module performs spectrophotometric analysis; ISE module measures electrical potential of electrolytes. Output: quantitative analyte concentrations sent to computer for analysis. Operation: used in professional clinical settings by laboratory personnel. Healthcare providers use results for diagnosis and monitoring of metabolic/renal conditions and electrolyte balance. Benefits: provides automated, high-throughput, multi-analyte testing capability in an open-reagent system.

## Clinical Evidence

Bench testing only. Studies included method comparison, precision, linearity, interference, and limit of quantitation. Results demonstrated performance according to specifications.

## Technological Characteristics

Fully automated, discrete, random-access analyzer. Photometric (Tungsten halogen lamp) and Potentiometric (ISE) sensing. XYZ probe movement with Teflon-coated washable probes. Barcode reader (Code 39, 128, 93, etc.). 96-well microplate reaction vessel. Bidirectional RS-232C connectivity. Software-driven control for end-point, kinetic, and fixed-time assays. Refrigerated reagent/sample carousel.

## Regulatory Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

## Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Predicate Devices

- Roche COBAS MIRA® Chemistry System ([K851172](/device/K851172.md))
- Medica Corp. EasyElectrolytes Analyzer ([K000926](/device/K000926.md))
- JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent ([K011900](/device/K011900.md))
- JAS Diagnostics, Inc. Creatinine (Single Vial) Reagent ([K003247](/device/K003247.md))
- JAS Diagnostics, Inc. Urea Nitrogen (BUN) Liquid Reagent ([K011596](/device/K011596.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k070704

B. Purpose for Submission:
New submission for the TRILOGY Analyzer for the determination Glucose, Creatinine, Urea nitrogen, Chloride, Potassium, and Sodium using previously cleared reagents and ISE test systems from the following submissions:
- JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent (k011900)
- JAS Diagnostics, Inc. Creatinine (Single Vial) Reagent (k003247)
- JAS Diagnostics, Inc. Urea Nitrogen (BUN) Liquid Reagent (k011596)
- Medica Corp. EasyElectrolytes Analyzer (k000926)

C. Measurand:
Glucose, Creatinine, Urea nitrogen, Chloride, Potassium, and Sodium

D. Type of Test:
Quantitative photometric and Ion Selective Electrode methods.

E. Applicant:
Drew Scientific, Inc.

F. Proprietary and Established Names:
TRILOGY Analyzer

G. Regulatory Information:
1. Regulation section:
21CFR - Sec 862.1345 - Glucose test system.
21CFR - Sec 862.1225 - Creatinine test system.
21CFR - Sec 862.1770 - Urea nitrogen test system.
21CFR - Sec 862.1170 - Chloride test system.
21CFR - Sec 862.1600 - Potassium test system.
21CFR - Sec 862.1665 - Sodium test system.
21CFR - Sec 862.2160 - Discrete Photometric Chemistry Analyzer for Clinical Use

2. Classification:
Class II for all except for Sec 862.2160 which is Class I

3. Product code:
CGA - Glucose Oxidase, Glucose
CGX - Alkaline Picrate, Colorimetry, Creatinine
CDQ - Urease And Glutamic Dehydrogenase, Urea Nitrogen
CGZ - Electrode, Ion-Specific, Chloride
CEM - Electrode, Ion Specific, Potassium
JGS - Electrode, Ion Specific, Sodium
JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
See indications for use below

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2. Indication(s) for use:

TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is an open system intended for clinical use in a professional setting for use with various chemistry assays that may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

TRILOGY is intended for the quantitative determination of glucose, creatinine and urea nitrogen in serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

TRILOGY includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium, and chloride in serum and urine. These measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.

3. Special conditions for use statement(s):

Prescription use

4. Special instrument requirements:

TRILOGY Analyzer

I. Device Description:

The TRILOGY Analyzer is composed of a carousel system for reagent bottles/tubes and sample tubes, a carousel compartment with refrigeration unit, barcode reader, a liquid distribution module, microplate platform, wash station and an optical module. Reagent bottles/tubes and sample tubes are loaded onto a specific reagent or sample carousel and are placed into the refrigeration unit of the TRILOGY Analyzer. Located within the refrigeration unit is a barcode scanner, which scans barcode-labeled reagents and specimens for identification. Reagents and specimens are acquired from the carousels via the liquid distribution module. The liquid distribution module is composed of two probes, the Sample (Small) probe and the Reagent (Large) probe. The Sample (Small) probe is used to aspirate and dispense volumes between 1 and 75 µL. It is primarily used for samples but can also be used for delivering small volumes of reagent. The Reagent (Large) probe is used to aspirate and dispense volumes between 40 and 250 µL and is primarily used for reagents. Reagents and samples are pipetted by the Reagent or Sample probes into the 96-well microplate located on the analyzer deck. In between each aspiration, both probes are rinsed internally and externally at the washing station to insure proper decontamination. Once the reagents and samples have been added to the 96-well plate, the optical module scans the plate and conducts light through each reaction well. The light received from each reaction well is measured by the spectrophotometer and the data sent to the computer for analysis.

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Serum or urine samples are pipetted from the sample carousel into the ISE module through the ion selective electrode injection well. The specimen is then introduced into the ISE module and pumped through each ion selective electrode. When the sample passes each individual electrode, the electrical potential of the individual electrode is measured and the data are sent to the computer for analysis.

See k011900, k003247, k011596, and k000926 for descriptive details for the reagents.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
- Roche Diagnostic Systems, Inc. Roche COBAS MIRA Chemistry System
- JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent
- JAS Diagnostics, Inc. Creatinine (Single Vial) Reagent
- JAS Diagnostics, Inc. Urea Nitrogen (BUN) Liquid Reagent
- Medica Corp. EasyElectrolytes Analyzer

2. Predicate 510(k) number(s):
k851172, k011900, k003247, k011596, and k000926

3. Comparison with predicate:

Comparison of TRILOGY Analyzer and Predicate Device – Roche COBAS MIRA®

|  Characteristics | Drew Scientific, Inc. TRILOGY Analyzer | Roche Diagnostics, Inc. Roche COBAS MIRA®  |
| --- | --- | --- |
|  Intended Use | TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is intended for clinical use in a professional setting for a variety of general chemistries. It includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride. | The COBAS MIRA® is a benchtop random access analyzer used for analysis in clinical chemistry with optional ion selective electrode module.  |
|  System Principle | Clinical chemistry analyses including end point, kinetic and fixed time assays in either a Routine or STAT mode | Selective analysis of chemistries in either a Routine or STAT mode  |

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|  Characteristics | Drew Scientific, Inc. TRILOGY Analyzer | Roche Diagnostics, Inc. Roche COBAS MIRA®  |
| --- | --- | --- |
|  Open/Closed Reagent System | Open | Open  |
|  Principles of Measurement | Spectrophotometric – parallel bi-chromatic measurement of light absorbance (Tungsten halogen lamp)
Potentiometric – Direct (Serum) Indirect (Urine) | Monochromatic measurement of light absorbance
Potentiometric – Direct (Serum) Indirect (Urine)  |
|  Light Source | Tungsten Halogen | Xenon Flash Tube  |
|  Reaction Vessel | 96-well Microplate | Six 12-Cuvette Segments  |
|  Throughput
Without ISE
With ISE | 170 tests/hour
280 tests/hour | 140 tests/hour  |
|  Specimen Type (Chemistry Methods) | Serum | Serum and Plasma  |
|  Specimen Capacity | 40 Tubes | 150 Tubes  |
|  Barcode Reader | Integrated | None  |
|  Barcode Formats | Code 39, Code 128, Code 93, Interleaved 2 of 5, Code 2 of 5, EAN, UPC A | Not applicable  |
|  Probe Movement | XYZ | XYZ  |
|  Primary Tubes | 1.5, 5, 7 and 10 mL | Sample Cup, 4, 10, 15 and 35 mL  |
|  Specimen Volume | 1 to 75 μL | 2 to 95 μL  |
|  Dilution of Specimens | Yes | Yes  |
|  Cross Contamination Prevention | Teflon® – coated, Washable Probes | Washable Probe  |
|  Reagent Type | Liquid | Liquid  |
|  Reagent Volume | 1 to 250 μL | 100 to 600 μL  |
|  Reagent Positions Onboard | Maximum 40 Tubes (10 mL)
Varies with Carousel Set | Varies with Reagent Rack Set  |
|  Reaction Volume | 80 to 450 μL | 150 to 600 μL  |
|  Host Interface | Bidirectional RS-232C | Bidirectional RS-232C  |
|  Calibration Curve | Linear and Non-linear | Linear and Non-linear  |
|  User Setting | Clinical Laboratory | Clinical Laboratory  |

Comparison of TRILOGY Analyzer and Predicate Device – Medica Corp. EasyElectrolytes

|  Characteristics | Drew Scientific, Inc. TRILOGY Analyzer | Medica Corp. EasyElectrolytes  |
| --- | --- | --- |
|  Intended Use | TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is intended for clinical use in a professional setting for a variety of general chemistries. It includes an optional Ion Selective Electrodes (ISE) module for the | The EasyElectrolytes Analyzer is designed for clinical laboratory use, for quantitative measurements of sodium, potassium, and chloride or lithium.  |

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|  Characteristics | Drew Scientific, Inc. TRILOGY Analyzer | Medica Corp. EasyElectrolytes  |
| --- | --- | --- |
|   | measurement of sodium, potassium and chloride. |   |
|  System Principle | Measurement of electrolytes in a biological matrix | Measurement of electrolytes in a biological matrix  |
|  Specimen Type | Serum and Urine | Serum, Plasma, Whole Blood and Urine  |
|  Principles of Measurement | Potentiometric – Direct (Serum) Indirect (Urine) | Potentiometric – Direct (Serum) Indirect (Urine)  |
|  Specimen Volume | 65 μL (Serum) 165 μL (Diluted Urine) | 55 μL (Specimen Container) 50 μL (Capillary) 300 μL (Diluted Urine)  |
|  Primary Tubes | 1.5, 5, 7 and 10 mL | Vacuum collection tube, syringe sample or capillary  |
|  Cross Contamination Prevention | Washable Probe | Washable Probe  |
|  Throughput
Serum
Urine | 180 tests/hour
111 tests/hour | 70 tests/hour
60 tests/hour  |
|  Host Interface | Bidirectional RS-232C | Bidirectional RS-232C  |
|  User Setting | Clinical Laboratory | Clinical Laboratory  |

Comparison of TRILOGY Analyzer with Predicate Device – JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent

|  Characteristics | Drew Scientific, Inc. TRILOGY Analyzer with JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent | JAS Diagnostics, Inc. Glucose Hexokinase (Liquid) Reagent  |
| --- | --- | --- |
|  Instrument | TRILOGY Analyzer | Various Instruments  |
|  Method | Enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase | Enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase  |
|  Specimen | Serum | Serum  |
|  Component Reagent Packaging | Single, reagent bottle, ready to use | Single, reagent bottle, ready to use  |
|  Format | Liquid | Liquid  |
|  Reagent | ATP, NAD, hexokinase, glucose-6-phosphate-dehydrogenase, sodium azide, stabilizers and fillers | ATP, NAD, hexokinase, glucose-6-phosphate-dehydrogenase, sodium azide, stabilizers and fillers  |

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Comparison of TRILOGY Analyzer and Predicate Device – JAS Diagnostics, Inc. Creatinine (Single Vial) Reagent

|  Characteristics | Drew Scientific, Inc. TRILOGY Analyzer with JAS Diagnostics, Inc. Creatinine (Single Vial) Reagent | JAS Diagnostics, Inc. Creatinine (Single Vial) Reagent  |
| --- | --- | --- |
|  Instrument | TRILOGY Analyzer | Various Instruments  |
|  Method | Kinetic modification of the Jaffe method using picric acid and sodium hydroxide | Kinetic modification of the Jaffe method using picric acid and sodium hydroxide  |
|  Specimen | Serum | Serum  |
|  Component Reagent Packaging | Single, reagent bottle, ready to use | Single, reagent bottle, ready to use  |
|  Format | Liquid | Liquid  |
|  Reagent | Picric acid, sodium hydroxide | Picric acid, sodium hydroxide  |

Comparison of TRILOGY Analyzer and Predicate Device – JAS Diagnostics, Inc. Urea Nitrogen (BUN) Liquid Reagent

|  Characteristics | Drew Scientific, Inc. TRILOGY Analyzer with JAS Diagnostics, Inc. Urea Nitrogen (BUN) Liquid Reagent | JAS Diagnostics, Inc. Urea Nitrogen (BUN) Liquid Reagent  |
| --- | --- | --- |
|  Instrument | TRILOGY Analyzer | Various Instruments  |
|  Method | Enzymatic method using urease | Enzymatic method using urease  |
|  Specimen | Serum | Serum  |
|  Component Reagent Packaging | Single, reagent bottle, ready to use | Single, reagent bottle, ready to use  |
|  Format | Liquid | Liquid  |
|  Reagent | α-Ketoglutarate, NADH, urease, GLDH, stabilizers and fillers | α-Ketoglutarate, NADH, urease, GLDH, stabilizers and fillers  |

K. Standard/Guidance Document Referenced (if applicable):
- CLSI - Evaluation of Precision Performance of Clinical Chemistry Devices - EP05-A2
- CLSI - Method Comparison and Bias Estimation Using Patient Samples - EP09-A2
- CLSI - Evaluation of the Linearity of Quantitative Analytical Methods - EP06-A
- CLSI - Protocols for Determination of Limits of Detection and Limits of Quantitation - EP17-A
- Guidance for Industry In Vitro Diagnostic Chloride Test System; Final - 7/6/1998
- Guidance for Industry In Vitro Diagnostic Creatinine Test System; Final - 7/2/1998
- Guidance for Industry In Vitro Diagnostic Glucose Test System; Final - 7/6/1998

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Guidance for Industry In Vitro Diagnostic Potassium Test System; Final - 7/6/1998
Guidance for Industry In Vitro Diagnostic Sodium Test System; Final - 7/6/1998
Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System; Final - 7/6/1998
Guidance for Off-the-Shelf Software Use in Medical Devices; Final - 9/9/1999
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - 5/11/2005
- IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1: General requirements
- IEC 61326 (02), Electrical equipment for measurement, control and laboratory use – EMC requirements
- EN 61326 (97) + A1 (98) + A2 (01) + A3 (03), Electrical equipment for measurement, control and laboratory use – EMC requirements
- FCC Part 15 (06), Telecommunication, Chapter 1: Federal communications commission, Part 15: Radio frequency devices
- ISO 14971 Medical devices -- Application of risk management to medical devices

## L. Test Principle:

Photometric methods and ISE see k011900, k003247, k011596, and k000926 for reagent principle details.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Precision studies were performed following the CLSI standard, EP5A-2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline,

Within-run precision studies consisted of assaying each control in replicates of 20 for one (1) run. Total precision studies for the clinical chemistry methods consisted of assaying each control in replicates of two (2), twice a day for a total of 20 days.

|  Precision – Clinical Chemistry  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Glucose Hexokinase |   |   | Creatinine |   |   | Urea Nitrogen (BUN)  |   |   |
|   | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3  |
|  Mean (mg/dL) | 72.3 | 102.7 | 291.2 | 1.26 | 7.17 | 11.57 | 8.42 | 12.25 | 50.49  |
|  Within-Run |  |  |  |  |  |  |  |  |   |
|  SD | 1.90 | 1.60 | 2.70 | 0.04 | 0.14 | 0.27 | 0.41 | 0.42 | 0.86  |
|  %CV | 2.6 | 1.5 | 0.9 | 3.2 | 1.9 | 2.3 | 4.9 | 3.4 | 1.7  |
|  Total |  |  |  |  |  |  |  |  |   |
|  SD | 3.10 | 2.90 | 5.10 | 0.05 | 0.21 | 0.44 | 0.54 | 0.49 | 1.27  |
|  %CV | 4.3 | 2.8 | 1.7 | 4.3 | 2.9 | 3.8 | 6.5 | 4.0 | 2.5  |

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|  Precision – ISE Serum  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | SODIUM |   |   | POTASSIUM |   |   | CHLORIDE  |   |   |
|   | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3  |
|  Mean (mmol/L) | 118.4 | 142.7 | 160.53 | 2.22 | 3.98 | 7.77 | 79.00 | 100.21 | 117.96  |
|  Within-Run |  |  |  |  |  |  |  |  |   |
|  SD | 0.70 | 0.70 | 0.78 | 0.02 | 0.01 | 0.02 | 0.37 | 0.26 | 0.26  |
|  %CV | 0.6 | 0.5 | 0.5 | 0.7 | 0.2 | 0.3 | 0.5 | 0.3 | 0.2  |
|  Total |  |  |  |  |  |  |  |  |   |
|  SD | 1.20 | 1.40 | 1.68 | 0.05 | 0.04 | 0.10 | 1.42 | 0.70 | 0.82  |
|  %CV | 1.0 | 1.0 | 1.0 | 2.1 | 1.1 | 1.3 | 1.8 | 0.7 | 0.7  |

Only within run precision studies were performed for the ISE urine methods:

|  Precision – ISE Urine  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Sodium |   | Potassium |   | Chloride  |   |
|   | Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2  |
|  Mean (mmol/L) | 92.0 | 159.0 | 36.59 | 63.30 | 96.25 | 142.94  |
|  Within-Run |  |  |  |  |  |   |
|  SD | 1.30 | 2.00 | 0.38 | 0.67 | 0.67 | 1.31  |
|  %CV | 1.5 | 1.2 | 1.0 | 1.1 | 0.7 | 0.9  |

b. Linearity/assay reportable range:

The range of measurement (dynamic range) for the photometric assays are supported by Linearity and Detection limit studies:

Glucose – 12 to 500 mg/dl

Creatinine – 0.2 to 20 mg/dl

Urea Nitrogen – 4.7 to 115.0 mg/dl

Samples for the linearity studies were prepared following the CLSI standard, EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. The procedure used to evaluate linearity was to assay a series of samples with known analyte concentrations using commercially available reference standard materials.

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|  Linearity – Clinical Chemistry  |   |   |   |
| --- | --- | --- | --- |
|  Key Statistics | Glucose Hexokinase | Creatinine | Urea Nitrogen (BUN)  |
|  Linearity Panel Members (N) | 11 | 11 | 9  |
|  Slope | 0.9986 | 1.004 | 0.9911  |
|  Intercept (mg/dL) | 2.2 | 0.38 | -2.20  |
|  Maximum Deviation from 100% | 2.7% at 210 mg/dL | 13.4% at 2.4 mg/dL | 14.8% at 14.5 mg/dL  |
|  Maximum Deviation from Linearity | 4.7 mg/dL (1.8%) at 260 mg/dL | -0.49 mg/dL (-2.0%) at 23.8 mg/dL | 3.32 mg/dL (2.6%) at 126.5 mg/dL  |
|  Range (mg/dL) | 11.0 – 508.0 | 0.05 – 23.80 | 0.50 – 126.50  |
|  Linearity – ISE Serum  |   |   |   |
| --- | --- | --- | --- |
|  Key Statistics | Sodium | Potassium | Chloride  |
|  Linearity Panel Members (N) | 11 | 11 | 10  |
|  Slope | 0.989 | 0.994 | 0.918  |
|  Intercept (mmol/L) | 3.60 | -0.04 | 14.69  |
|  Systematic Error (mmol/L): |  |  |   |
|  Observed | 1.32 | 0.11 | 1.5%  |
|  Allowed | 1.40 | 0.14 | 1.8%  |
|  Range (mmol/L) | 104.30 – 209.00 | 0.94 – 11.79 | 52.47 – 172.07  |
|  Linearity – ISE Urine  |   |   |   |
| --- | --- | --- | --- |
|  Key Statistics | Sodium | Potassium | Chloride  |
|  Linearity Panel Members (N) | 9 | 9 | 8  |
|  Slope | 0.969 | 0.951 | 0.968  |
|  Intercept (mmol/L) | 1.80 | -1.04 | 2.82  |
|  Systematic Error (mmol/L) |  |  |   |
|  Observed | 0.60 | 1.01 | 1.7%  |
|  Allowed | 0.83 | 1.05 | 1.8%  |
|  Range (mmol/L) | 13.00 – 349.70 | 2.40 – 187.87 | 39.07 – 402.97  |

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The cleared calibrators used for the performance studies were as follows:

- Chemistry Methods JAS Chemistry Calibrator
JAS Diagnostics, Inc.
k020454

- ISE Methods - Calibrant A and Calibrant B
Medica Corporation
k000926

d. Detection limit:

The photometric assays were evaluated using EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.

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|  LOB/LOD/LOQ Data – Clinical Chemistry  |   |   |   |
| --- | --- | --- | --- |
|   | Glucose Hexokinase | Creatinine | Urea Nitrogen (BUN)  |
|  LOB (mg/dL) | 8.31 | 0.11 | 3.71  |
|  LOD (mg/dL) | 12.0 | 0.17 | 4.7  |
|  LOQ
(mg/dL) | 16.6 | 0.23 | 5.5  |
|  % CV | 13.66 | 16.88 | 11.47  |

Not Applicable for ISE methods

e. Analytical specificity:

Interference studies were performed following the CLSI standard, EP7-A: Interference Testing in Clinical Chemistry; Approved Guideline. The procedure used to evaluate interference was to assay a series of samples with known concentrations of interferent. Percent recoveries were calculated for each sample with interferent versus the matched sample without interferent. Interference was defined as the level at which less than a 10% difference was observed between a sample with and without interferent. Interferent concentrations above those stated in Table 3 would contribute to invalid patient results.

|  Interference – Clinical Chemistry  |   |   |   |
| --- | --- | --- | --- |
|  Interferent | Glucose Hexokinase | Creatinine | Urea Nitrogen (BUN)  |
|  Hemoglobin (mg/dL) | 200 | No interference up to 1000 | 1000  |
|  Bilirubin (mg/dL) | 23.4 | 6.7 | No interference up to 39.3  |
|  Triglycerides (mg/dL) | 370 | 1117.5 | No interference up to 994  |

The below table reports the concentration of interferent where interference was not observed with a specific ISE serum method assayed by the TRILOGY Analyzer.

|   | Interfering substance: Bilirubin  |
| --- | --- |
|  Analyte concentration |   |
|  Sodium |   |
|  162 mmol/l | 35.3 mg/dl  |
|  189 mmol/l | 20.2 mg/dl  |
|  Potassium |   |
|  4.41 mmol/l | 41.4 mg/dl  |
|  8.26 mmol/l | 21.7 mg/dl  |
|  Chloride |   |
|  107 mmol/l | 41.3 mg/dl  |
|  130 mmol/l | 21.1 mg/dl  |

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|   | Interfering substance: Hemoglobin  |
| --- | --- |
|  Sodium |   |
|  140 mmol/l | 679 mg/dl  |
|  149 mmol/l | 871 mg/dl  |
|  Potassium |   |
|   | Do not use hemolyzed samples  |
|   | Do not use hemolyzed samples  |
|  Chloride |   |
|  100 mmol/l | 921 mg/dl  |
|  113 mmol/l | 1000 mg/dl  |
|   | Interfering substance: Triglycerides  |
|  Sodium |   |
|  140 mmol/l | 2296 mg/dl  |
|  148 mmol/l | 2038 mg/dl  |
|  Potassium |   |
|  4.20 mmol/l | 2296 mg/dl  |
|  6.85 mmol/l | 2366 mg/dl  |
|  Chloride |   |
|  99.5 mmol/l | 2296 mg/dl  |
|  110.4 mmol/l | 2366 mg/dl  |

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
**Clinical Chemistry Methods**

Serum specimens were assayed using the TRILOGY Analyzer and Roche COBAS MIRA® for each clinical chemistry method. Regression statistics were calculated as follows:

**Method Comparison Studies – Clinical Chemistry Methods**

|  Method Comparison – Clinical Chemistry  |   |   |   |
| --- | --- | --- | --- |
|  Key Statistics | Glucose Hexokinase | Creatinine | Urea Nitrogen (BUN)  |
|  N | 62 | 69 | 70  |
|  Corr. Coeff. (R) | 0.9946 | 0.9945 | 0.9956  |
|  Slope* (95% CI) | 0.9902 (0.9643 – 1.016) | 0.9860 (0.9614 – 1.011) | 1.088 (1.064 – 1.112)  |
|  Intercept* (mg/dL) (95% CI) | 7.0 (2.8 – 11.2) | 0.03 (-0.11 – 0.16) | -2.43 (-3.30 – -1.55)  |
|  Range (mg/dL) | 42.0 – 463.0 | 0.7 – 14.7 | 4.8 – 80.0  |

* = Data presented are Deming linear regression statistics

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# ISE Serum Methods

Serum specimens were assayed using the TRILOGY Analyzer with ISE module and Medica EasyElectrolytes for each ISE serum method. Regression statistics were calculated as follows:

## Method Comparison Studies – ISE Serum Methods

|  Method Comparison – ISE Serum  |   |   |   |
| --- | --- | --- | --- |
|  Key Statistics | Sodium | Potassium | Chloride  |
|  N | 101 | 101 | 94  |
|  Corr. Coeff. (R) | 0.9869 | 0.9979 | 0.9972  |
|  Slope*
(95% CI) | 0.972
(0.941 – 1.004) | 1.004
(0.991 – 1.017) | 0.854
(0.840 – 0.867)  |
|  Intercept* (mmol/L)
(95% CI) | 6.2
(1.8 – 10.6) | 0.11
(0.05 – 0.17) | 14.8
(13.5 – 16.2)  |
|  Range (mmol/L) | 107.0 – 183.0 | 2.1 – 9.6 | 56.0 – 149.0  |

*= Data presented are Deming linear regression statistics

# ISE Urine Methods

Urine specimens were assayed using the TRILOGY Analyzer with ISE module and Medica EasyElectrolytes for each ISE urine method. Regression statistics were calculated as follows:

## Method Comparison Studies – ISE Urine Methods

|  Method Comparison – ISE Urine  |   |   |   |
| --- | --- | --- | --- |
|  Key Statistics | Sodium | Potassium | Chloride  |
|  N | 76 | 77 | 76  |
|  Corr. Coeff. (R) | 0.9972 | 0.9969 | 0.9967  |
|  Slope*
(95% CI) | 0.989
(0.971 – 1.006) | 1.020
(1.002 – 1.039) | 1.046
(1.026 – 1.065)  |
|  Intercept* (mmol/L)
(95% CI) | 0.69
(-2.33 – 3.71) | -0.521
(-1.789 – 0.747) | -3.36
(-7.12 – 0.39)  |
|  Range (mmol/L) | 14.3 – 291.9 | 11.27 – 145.6 | 40.3 – 353.2  |

* = Data presented are Deming linear regression statistics

b. Matrix comparison:
See ISE urine method comparison above

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable

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c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
See k011900, k003247, k011596, and k000926

## N. Instrument Name:
TRILOGY Analyzer

## O. System Descriptions:

1. Modes of Operation:
Random access routine and stat modes

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐

3. Specimen Identification:
Barcode

4. Specimen Sampling and Handling:
Sample tube carousel

5. Calibration:
End-point, enzymatic and quadratic curve-fitting can be chosen to analyze data. Calibration curve-fitting parameters such as Linear (linear regression, bi-logarithmic regression, weighted linear) and Non-linear (Logit-Log, Exponential and Polynomial) are available.

6. Quality Control:
The operational software of the TRILOGY Analyzer contains a database, which is capable of storing results from previous analyses. The operator can view raw data and graphs for each clinical chemistry and ISE method. QC options also allow displays for evaluating data using Westgard Rules, viewing Levey-Jennings plots, reviewing statistical performance and exporting the QC data in Text File (TXT)

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format.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

None

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K070704](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K070704)

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