Tru Liver Health Test Panel

K251074 · Truvian Health · CJE · Dec 19, 2025 · Clinical Chemistry

Device Facts

• Record ID: K251074
• Device Name: Tru Liver Health Test Panel
• Applicant: Truvian Health
• Product Code: CJE · Clinical Chemistry
• Decision Date: Dec 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

The Tru Liver Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Liver Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. The Tru Liver Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in diagnosing the following disorders in adults 18 years of age or older: Alkaline Phosphatase (ALP): Liver, bone, parathyroid, and intestinal diseases. Aspartate Aminotransferase (AST): Certain types of liver and heart diseases. Alanine Aminotransferase (ALT): Certain liver (e.g., viral hepatitis and cirrhosis) and heart diseases.

Device Story

TruSystem is an automated, integrated in vitro diagnostic platform comprising the Tru Analyzer and a Single-Use Consumable Kit (Disc and Support Pack). It processes lithium-heparinized venous whole blood samples to provide quantitative clinical chemistry results. The analyzer automates sample handling, centrifugation, thermal control, and detection using an onboard high-precision pipettor, camera, and electronics. Operators load the sample and kit into the analyzer drawer; the system performs automated self-tests and internal quality control checks. Results are displayed on a touchscreen interface. If QC fails, the system suppresses reporting and provides error codes. The device is intended for use in clinical laboratories or point-of-care settings by healthcare personnel. It eliminates the need for external calibration or specialized infrastructure, providing rapid diagnostic information to assist physicians in managing liver and heart-related conditions.

Clinical Evidence

Bench testing only. Performance evaluated via precision (CLSI EP05-A3), linearity (CLSI EP06), interference (CLSI EP07-A3/EP37), and detection limits (CLSI EP17-A2). Method comparison study (N=193-272 samples) against legally marketed comparators showed high correlation (R=0.997-0.999) and acceptable accuracy across medical decision points. No clinical diagnostic sensitivity/specificity studies were required.

Technological Characteristics

Single-use consumable kit containing dried reagents (2-Oxoglutarate, LDH, L-Aspartate, MDH, NADH, p-NPP), buffers, and pipette tips. Photometric/colorimetric sensing principle. Operates on Tru Analyzer. Validated for use up to 2,000 m altitude. Connectivity via barcode-managed lot/calibration data. Sterilization method not specified.

Indications for Use

Indicated for adults 18+ years for quantitative determination of ALP, AST, and ALT in lithium-heparinized venous whole blood to aid in diagnosis of liver, bone, parathyroid, intestinal, and heart diseases. Contraindicated for use above 2,000 m altitude; ALP results invalid in samples with hemolysis ≥ 50 mg/dL.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Predicate Devices

• Skyla Comprehensive Metabolic Panel (K171971)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY

## I Background Information:

A 510(k) Number

K251074

B Applicant

Truvian Health

C Proprietary and Established Names

Tru Liver Health Test Panel

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CJE | Class II | 862.1050-Alkaline phosphatase or isoenzymes test system | CH - Clinical Chemistry |
| CIT | Class II, meets the limitations of exemptions in 862.9(c)(9) | 862.1100-Aspartate amino transferase (AST/SGOT) test system | CH - Clinical Chemistry |
| CKA | Class I, meets the limitations of exemptions in 862.9(c)(9) | 862.1030-Alanine amino transferase (ALT/SGPT) test system | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

New device

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Measurand:

Alkaline phosphatase (ALP)
Alanine amino transferase (ALT)
Aspartate amino transferase (AST)

C Type of Test:

Quantitative, Photometric/Colorimetric

III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

B Indication(s) for Use:
The Tru Liver Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Liver Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.

The Tru Liver Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in diagnosing the following disorders in adults 18 years of age or older:

Alkaline Phosphatase (ALP): Liver, bone, parathyroid, and intestinal diseases.

Aspartate Aminotransferase (AST): Certain types of Liver and heart diseases.

Alanine Aminotransferase (ALT): Certain Liver (e.g., viral hepatitis and cirrhosis) and heart diseases.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

The alkaline phosphatase (ALP) analyte is sensitive to hemolysis, and the instrument flags samples with hemolysis values of 50 mg/dL or higher. This results in approximately 5% of samples being flagged, preventing result reporting. Therefore, implementing an alternative backup method not subject to hemolysis interference is recommended.

The instrument was validated up to an altitude of 2,000 m (6562 ft). The Tru Liver Health Test Panel should not be used above 2,000 m (6562 ft).

D Special Instrument Requirements:

Tru Analyzer

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IV Device/System Characteristics:

# A Device Description:

The Tru Liver Health Test Panel contains the following reagents:

| Component | Quantity per Kit |
| --- | --- |
| 2-Oxoglutarate | 75.2 μg |
| Lactate Dehydrogenase | >48.0 mU |
| L-Aspartate | 1,264.4 μg |
| Malate Dehydrogenase | >6.6 mU |
| Nicotinamide Adenine Dinucleotide (Reduced) | 9.2 mg |
| p-Nitrophenyl Phosphate | 8.4 μg |
| Buffers, Preservatives, Stabilizers | |

The single-use consumable kit houses all the components needed to process as well as analyze samples on the Tru Analyzer, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards of at the end of the run. The Support Pack contains a feature to accept a standard 4 mL blood tube. The Support Pack also houses 22 pipette tips for transferring and mixing samples and reagents, 11 dilution wells to support reagent processing activities within the test system (e.g., sample dilution, reagent dilution, rehydration of dried reagents), and $6 \times 2 \mathrm{ml}$ tubes that contain additional wet and dry reagents.

# B Principle of Operation:

Alkaline phosphatase (ALP): Alkaline phosphatase hydrolyzes $\rho$ -NPP in a metal-ion buffer and forms $\rho$ -nitrophenol and phosphate. $\rho$ -nitrophenol has an intense color at $405~\mathrm{nm}$ in an alkaline solution. The formation of the color can be followed kinetically, and this rate of change is proportional to the concentration of alkaline phosphatase in the sample.

$$
\mathrm {p - N P P} + \mathrm {H 2 O A l k a l i n e P h o s p h a t a s e} \rightarrow \mathrm {P h o s p h a t e} + \mathrm {p - N P}
$$

Alanine aminotransferase (ALT): ALT catalyzes the transfer of the amino group from alanine to oxoglutarate ( $\alpha$ -KG) with the formation of glutamate and pyruvate. This last compound is reduced to lactate in a reaction catalyzed by lactate dehydrogenase (LDH). In this same reaction, an equivalent amount of NADH is oxidized to NAD. The resulting rate of decrease in absorbance at $340~\mathrm{nm}$ is directly proportional to the activity of ALT in the sample.

$$
\mathrm {L} - \text {a l a n i n e} + \alpha - \mathrm {K G} \quad \text {A l a n i n e A m i n o t r a n s f e r a s e} \rightarrow \text {P y r u v a t e} + \mathrm {L} - \text {g l u t a m a t e}
$$

Aspartate aminotransferase (AST): Aspartate aminotransferase (AST) catalyzes the transfer of the amino group from aspartate to oxoglutarate ( $\alpha$ -KG) with the formation of glutamate and

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oxaloacetate (OAA). This last compound is reduced to malate in a reaction catalyzed by malate dehydrogenase (MDH). In this same reaction, an equivalent amount of NADH is oxidized to NAD. The resulting decrease in absorbance at 340 nm is followed spectrophotometrically and the rate is directly proportional to the amount of AST present in the sample.

$$
\mathrm{L}\text{-aspartate} + \alpha\text{-KG} \text{ Aspartate Aminotransferase} \rightarrow \mathrm{OAA} + \mathrm{L}\text{-glutamate}
$$

$$
\mathrm{OAA} + \mathrm{NADH} \cdot \mathrm{MDH} \rightarrow \mathrm{L}\text{-malate} + \mathrm{NAD}
$$

V Substantial Equivalence Information:

A Predicate Device Name(s):

Comprehensive Metabolic Panel

B Predicate 510(k) Number(s):

K171971

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K251704 | K171971 |
| --- | --- | --- |
| Device Trade Name | Tru Liver Health Test Panel | Comprehensive Metabolic Panel |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | In vitro quantitative determination of Alkaline phosphatase (ALP), Aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) concentrations in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. | Same |
| General Device Characteristic Differences | | |
| Specimen Type | Lithium-heparinized venous whole blood | Lithium-heparinized venous whole blood, lithium-heparinized plasma, or serum |

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| Device & Predicate Device(s): | K251704 | K171971 |
| --- | --- | --- |
| Analytical Measuring Range | ALP: 25 – 1200 U/L
ALT: 15 – 500 U/L
AST: 11 – 700 U/L | ALP: 41 – 1500 U/L
ALT: 20 – 500 U/L
AST: 20 – 1000 U/L |

VI Standards/Guidance Documents Referenced:

- CLSI (Clinical & Laboratory Standards Institute) EP05-A3 - Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline -Third Edition
- CLSI EP06 - Evaluation of the Linearity of Quantitative Measurement Procedures – Second Edition
- CLSI EP07-A3 - Interference Testing in Clinical Chemistry - Third Edition
- CLSI EP17-A2 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline -Second Edition
- CLSI EP37 - Supplemental Tables for Interference Testing in Clinical Chemistry -First Edition

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

A. Reproducibility with Control Materials: This study was designed according to CLSI EP05-A3. The study was conducted at 3 external point-of-care (POC) sites, with 3 analyzers per site and at least 3 POC operators per site. Testing was conducted over 5 days using a single lot of consumables and consisted of 3 levels of control samples at low, medium, and high concentrations, with 6 replicates run per day, 3 run in the morning and 3 run in the afternoon (each replicate is run on an individual instrument). Overall, there were at least 90 replicates for each precision control sample level (3 sites x 1 sample x 3 replicates per run x 2 runs per day x 5 days = 90 replicates). The total precision as well as within run, between day, and between site precision were estimated. Results are displayed below:

| | | | | Within-Run | | Between-Run | | Between-Day | | Between-Site | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte (U/L) | Sample | N | Mean | SD | CV % | SD | CV % | SD | CV | SD | CV % | SD | CV% |
| ALP | C1 | 91 | 71 | 4 | 4.9 | 0 | 0.0 | 1 | 1.4 | 1 | 1.9 | 4 | 5.5 |
| ALP | C2 | 91 | 120 | 6 | 4.6 | 0 | 0.0 | 2 | 1.2 | 1 | 0.9 | 6 | 4.9 |
| ALP | C3 | 92 | 373 | 8 | 2.2 | 2 | 0.5 | 0 | 0.0 | 7 | 1.9 | 11 | 2.9 |
| ALT | C1 | 92 | 62 | 2 | 2.9 | 1 | 1.1 | 0 | 0.0 | 2 | 3.2 | 3 | 4.5 |
| ALT | C2 | 91 | 291 | 6 | 1.9 | 0 | 0.0 | 3 | 0.9 | 3 | 1.1 | 7 | 2.4 |
| ALT | C3 | 92 | 427 | 5 | 1.1 | 2 | 0.5 | 3 | 0.6 | 4 | 1.0 | 7 | 1.7 |

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| | | | | Within-Run | | Between-Run | | Between-Day | | Between-Site | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte (U/L) | Sample | N | Mean | SD | CV % | SD | CV % | SD | CV | SD | CV % | SD | CV% |
| AST | C1 | 92 | 57 | 1 | 1.9 | 0.3 | 0.4 | 0.4 | 0.7 | 2 | 3.6 | 2 | 4.1 |
| AST | C2 | 91 | 292 | 6 | 2.0 | 0 | 0.0 | 3 | 1.0 | 4 | 1.4% | 8 | 2.7% |
| AST | C3 | 92 | 508 | 7 | 1.3 | 3 | 0.7 | 4 | 0.7 | 5 | 1.1 | 10 | 2.0 |

B. Whole Blood Precision: This study was evaluated at four sites collecting samples from the intended use population with normal and abnormal analyte levels. At least 20 subjects were enrolled at each site and for each test subject, eight replicates were measured across four instruments and two operators. The SD and CV% precision estimates were calculated by pooling subject standard deviations and/or % CV for predefined low, medium or high sub-intervals selected to represent normal and abnormal regions of the analytical measuring range and encompassing medical decision levels. Pooled imprecision is considered a representative estimate of reproducibility that include variability of sites, instruments, operators, days and repeatability.

| Analyte | Range | Subject (N) | Replicate (N) | Mean | SD | CV% |
| --- | --- | --- | --- | --- | --- | --- |
| ALP (U/L) | 25–130 | 66 | 487 | 79.4 | 4.3 | 5.8 |
| ALP (U/L) | 130–300 | 16 | 122 | 194.1 | 5.9 | 3.1 |
| ALP (U/L) | 300–1200 | 7 | 47 | 655.7 | 20.4 | 4.2 |
| ALT (U/L) | 15–30 | 39 | 270 | 20.9 | 1.4 | 6.5 |
| ALT (U/L) | 30–100 | 23 | 172 | 47.7 | 1.8 | 3.9 |
| ALT (U/L) | 100–500 | 7 | 56 | 204.8 | 9.9 | 4.4 |
| AST (U/L) | 10–30 | 57 | 444 | 19.0 | 1.2 | 6.7 |
| AST (U/L) | 30–100 | 22 | 165 | 45.4 | 1.5 | 3.5 |
| AST (U/L) | 100–700 | 6 | 44 | 141.1 | 5.1 | 3.7 |

C. Whole Blood Between-Lot Precision: 22 subjects consisting of 6 healthy individuals and 16 individuals in various disease states were enrolled at a single point-of-care clinical site and tested across 3 lots of the candidate panel on 3 individual Tru Analyzers by 2 operators. A total of 6 replicates per subject participant, 2 replicates per lot, were tested by 1 of the 2 operators. Results below present the number of subjects evaluated, the % difference from the median and pooled %CV by lot and by analyte. The elevated median relative difference percentages observed for AST analyte Lots B and C resulted from values falling near the limit of quantification.

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| Analyte (U/L) | Subjects per Lot | Median relative difference % | | | Pooled %CV | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Lot-A | Lot-B | Lot-C | Lot-A | Lot-B | Lot-C |
| ALP | 22 | -0.3 % | -0.6 % | -1.1 % | 4.0 % | 6.5 % | 5.7 % |
| ALT* | 18 | -0.1 % | -0.3 % | 0.3 % | 6.0 % | 10.4 % | 3.6 % |
| AST | 22 | -0.7 % | 3.5 % | -4.0 % | 5.5 % | 5.7 % | 6.0 % |

*a replicate for ALT Lot-B was identified as a statistical outlier and the table below provides the results without the outlier included.

| Analyte (U/L) | Subjects per Lot | Median relative difference % | | | Pooled %CV | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Lot-A | Lot-B | Lot-C | Lot-A | Lot-B | Lot-C |
| ALT | 18 | -0.1 % | -0.3 % | 0.3 % | 6.0 % | 6.4 % | 3.6 % |

D. Control Between-Lot Reproducibility: To evaluate the lot-to-lot reproducibility, 3 control samples (low, medium and high) were tested on 3 Tru Analyzers using 3 lots of the candidate test. Each sample level was tested with at least five (5) replicates on one Tru Analyzer each day with each single-use consumable kit lot over 3 days to achieve a minimum of fifteen (15) replicates per sample level and kit lot. Results are displayed below: -

| Assay | Analyte (U/L) | N | Grand Mean | Lot Mean | | | CV | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| ALP | Low | 45 | 71.1 | 72.4 | 70.4 | 70.4 | 4.2% | 6.3% | 5.9% |
| ALP | Medium | 45 | 118.8 | 117.4 | 121.3 | 117.7 | 5.7% | 3.1% | 3.3% |
| ALP | High | 45 | 379.6 | 383.0 | 373.7 | 382.0 | 2.0% | 3.3% | 3.2% |
| ALT | Low | 45 | 58.5 | 58.7 | 58.1 | 58.8 | 2.7% | 2.7% | 2.6% |
| ALT | Medium | 45 | 288.4 | 289.6 | 288.4 | 287.2 | 1.8% | 1.7% | 1.3% |
| ALT | High | 45 | 421.0 | 425.5 | 415.8 | 421.8 | 1.9% | 2.8% | 1.7% |
| AST | Low | 45 | 56.1 | 57.3 | 55.2 | 55.7 | 2.40% | 2.0% | 1.9% |
| AST | Medium | 45 | 290.7 | 292.3 | 290.6 | 289.4 | 1.3% | 1.2% | 1.3% |
| AST | High | 45 | 504.2 | 510.1 | 498.3 | 504.1 | 1.6% | 2.9% | 1.9% |

# 2. Linearity:

The linearity study was conducted in accordance with CLSI EP06-Ed2. Linearity was assessed with multiple panels of samples. The linear range for the ALP, ALT, and AST assays were determined by testing nine (9) samples containing varying concentrations of analyte. Each sample was tested in quadruplicate, using one (1) kit lot, across 4 Tru Analyzers, on a single day. The results of the study supported the claimed linear interval for ALP, ALT, and AST. Within the claimed analytical measuring range, the maximum observed deviation for ALP, ALT, and AST are $7.3\%$ , $1.5\%$ and $5.5\%$ , respectively.

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# 3. Analytical Specificity/Interference:

The sponsor conducted an analytical specificity study according to CLSI EP07-A3 and EP37 guidelines. Testing was performed with contrived lithium heparin whole blood samples from a healthy donor population, with two (2) analyte concentration levels targeted based on recommended levels in CLSI EP07-A3. Potentially interfering substances were prepared in the appropriate diluent and then added to the low and high contrived whole blood samples to create test samples. For any substances identified as an interferent, dose response testing was conducted to assess the highest concentration limit below which no significant interference was observed. The sponsor defined significant interference as bias $>10\%$ between the test and control samples and the results are displayed below:

| Substance (mg/dL) | Max Concentration without Interference mg/dL | | |
| --- | --- | --- | --- |
| | ALP | ALT | AST |
| Triglycerides | 1037 | 1037 | 1037 |
| Hemoglobin | 48 | 545 | 159 |
| Conjugated Bilirubin | 22.5 | 22.5 | 22.5 |
| Unconjugated Bilirubin | 31.5 | 27.5 | 14.0 |
| Substance | Max Concentration without Interference | | | |
| --- | --- | --- | --- | --- |
| | ALP | AST | ALT | Units |
| Acetaminophen | 15.6 | 15.6 | 15.6 | mg/dL |
| Acetylsalicylic acid | 3.0 | 3.0 | 3.0 | mg/dL |
| Ampicillin | 7.5 | 7.5 | 7.5 | mg/dL |
| Cefoxitin | 330 | 660 | 495 | mg/dL |
| Cyclosporine | 0.18 | 0.18 | 0.18 | mg/dL |
| Doxycycline | 1.35 | 1.8 | 1.8 | mg/dL |
| Heparin | 3,300 | 3,300 | 3,300 | U/L |
| Ibuprofen | 21.9 | 21.9 | 21.9 | mg/dL |
| Levodopa (L-Dopa) | 0.75 | 0.75 | 0.75 | mg/dL |
| Methyldopa | 2.25 | 2.25 | 2.25 | mg/dL |
| Metronidazole | 12.3 | 12.3 | 12.3 | mg/dL |
| Phenylbutazone | 24.1 | 32.1 | 32.1 | mg/dL |
| Rifampicin | 4.8 | 4.8 | 4.8 | mg/dL |
| Theophylline | 6.0 | 6.0 | 6.0 | mg/dL |
| Acetylcysteine | 15 | 15 | 15 | mg/dL |
| Phenytoin | 0.75 | 0.75 | 0.75 | mg/dL |
| Phenytoin | 0.8 | 0.8 | 0.8 | mg/dL |

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| Substance | Max Concentration without Interference | | | |
| --- | --- | --- | --- | --- |
| | ALP | AST | ALT | Units |
| Ascorbic Acid | 5.25 | 5.25 | 5.25 | mg/dL |
| Caffeine | 8.1 | 10.8 | 10.8 | mg/dL |
| Cephalothin | 135 | 135 | 180 | mg/dL |
| Cimetidine | 3.0 | 3.0 | 3.0 | mg/dL |
| Salicylic Acid | 2.86 | 2.86 | 2.86 | mg/dL |

The sponsor provided adequate information to support hemolysis, icterus and lipemia flags will detect samples subject to these interferences.

## 4. Detection Limit and Assay Reportable Range:

The Limit of Blank (LoB) was determined in accordance with the classical approach provided in section 5.3 of CLSI EP17-A2. LoB was determined by running four (4) blank samples on four (4) Tru Analyzers over three (3) days of testing with five (5) replicates per sample for a total of sixty (60) tests for each single-use consumable kit lot.

The LoD (Limit of Detection) and LoQ (Limit of Quantitation) were determined based on recommendations from CLSI EP17-A2. The LoQ corresponds to the lowest concentration of analyte in a sample that had a $\mathrm{CV} \leq 20\%$ .

The results of the studies are summarized below and support the claimed measuring ranges for each test.

| (U/L) | LoB | LoD | LOQ |
| --- | --- | --- | --- |
| ALP | 6.15 | 12 | 22 |
| AST | 2.29 | 4 | 11 |
| ALT | 5.80 | 8 | 11 |

## 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Traceability:

The sponsor claims the following regarding traceability:

| Assay | Traceability |
| --- | --- |
| ALP | JCCLS standard-CRM001d |
| AST | Traceable to IFCC through a commercially available method |

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| Assay | Traceability |
| --- | --- |
| ALT | Traceable to IFCC through a commercially available method |

**Sample Stability:**

Sample Stability studies performed demonstrate that samples measured on the candidate tests are stable for 60-minutes post-collection.

**Altitude Effects:**

An altitude study was conducted to evaluate performance of ALP, ALT, and AST at sea-level and an altitude of 2000 meters. This study supports the device performance at altitudes of up to 2000 meters.

6. **Assay Cut-Off:**

Not Applicable.

B **Comparison Studies:**

1. **Method Comparison with Predicate Device:**

A method comparison study was conducted to establish the performance characteristics of the Tru Kidney Liver Test Panel on the Tru Analyzer when used to analyze lithium heparin whole blood clinical specimens. Whole blood samples from apparently healthy patient and from patients with acute or chronic health conditions were collected from 5 point-of-care sites, tested by at least 3 point-of-care operators per site, on at least 4 Tru Analyzers per site, using 5 lots of reagents. Results compared against legally marketed comparators are displayed below. The data demonstrated that accuracy was consistent across sites. Differences at the medical decision points were reviewed and found acceptable.

| Analyte (U/L) | N | Range (U/L) | Slope | Intercept | R |
| --- | --- | --- | --- | --- | --- |
| ALP | 259 | 30–1185 | 1.04 (1.02, 1.06) | -3.06 (-4.81, -1.32) | 0.997 |
| AST | 272 | 11–673 | 1.00 (1.00, 1.00) | 1.00 (0.50, 1.00) | 0.999 |
| ALT | 193 | 15–464 | 0.91 (0.90, 0.93) | 2.62 (2.04, 3.22) | 0.999 |

2. **Matrix Comparison:**

Not Applicable.

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C Clinical Studies:

1. Clinical Sensitivity:
Not Applicable.

2. Clinical Specificity:
Not Applicable.

3. Clinical Cut-Off
Not Applicable.

4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not Applicable.

D Expected Values/Reference Range:

The reference ranges were established based on scientific literature. *

| Analyte | | Reference Interval | Units |
| --- | --- | --- | --- |
| ALP | | 37–108 | U/L |
| AST | Male | < 35 | U/L |
| | Female | < 31 | U/L |
| ALT | Male | < 45 | U/L |
| | Female | < 34 | U/L |

*C. A. Burtis, E. R. Ashwood, and D. E. Bruns. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed., Elsevier Saunders, St. Louis, (2006).

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

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