Cholesterol2

K203597 · Abbott Ireland Diagnostics Division · CHH · Jun 30, 2022 · Clinical Chemistry

Device Facts

• Record ID: K203597
• Device Name: Cholesterol2
• Applicant: Abbott Ireland Diagnostics Division
• Product Code: CHH · Clinical Chemistry
• Decision Date: Jun 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Cholesterol2 assay is used for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. The Cholesterol2 assay is to be used as an aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Device Story

Cholesterol2 is an automated clinical chemistry assay for human serum or plasma. It uses an enzymatic procedure: cholesterol esters are hydrolyzed by cholesterol esterase to cholesterol and fatty acids; cholesterol is oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide; hydrogen peroxide couples with TODB and 4-aminoantipyrine to form a chromophore (quinoneimine dye) measured at 604 nm. The device is used on the ARCHITECT c8000 System in clinical laboratories by trained personnel. Output is a quantitative cholesterol concentration (mg/dL). Results assist clinicians in diagnosing and managing lipid metabolism disorders and hypercholesterolemia. The assay provides a reportable range of 2–2992 mg/dL, aiding patient monitoring and therapeutic decision-making.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A3 (n=80 per sample). Linearity confirmed across 5–748 mg/dL range. Interference testing per CLSI EP07 showed no significant interference from endogenous/exogenous substances at specified levels. Method comparison (n=138) against predicate showed high correlation (r=1.00) and minimal bias at medical decision points. Matrix comparison confirmed equivalence across serum and heparinized plasma types.

Technological Characteristics

Enzymatic esterase-oxidase assay. Reagents: cholesterol esterase, cholesterol oxidase, TODB, 4-aminoantipyrine, peroxidase, sodium azide. Measurement: spectrophotometric at 604 nm. Traceable to Abell-Kendall reference method. Designed for ARCHITECT c8000 System. Software: assay file required for instrument operation.

Indications for Use

Indicated for the quantitation of cholesterol in human serum or plasma to aid in the diagnosis and treatment of disorders involving excess blood cholesterol and lipid/lipoprotein metabolism disorders.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• Cholesterol (k981652)

Submission Summary (Full Text)

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June 30, 2022

Abbott Ireland Diagnostics Division Tracy Schmidt Senior Specialist Regulatory Affairs Lisnamuck, Longford Co. Longford, Ireland

Re: K203597

Trade/Device Name: Cholesterol2 Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets the limitation to the exemption 21 CFR 862.9(c)(4) Product Code: CHH Dated: March 25, 2022 Received: March 28, 2022

Dear Tracy Schmidt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k203597

Device Name Cholesterol2

Indications for Use (Describe)

The Cholesterol2 assay is used for the quantitation of cholesterol in human serum or the ARCHITECT c System. The Cholesterol2 assay is to be used an an aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| | <span> <span style="font-size:120%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(k) Summary (Summary of Safety and Effectiveness)

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

### I. 510(k) Number

k203597

# II. Applicant Name

Abbott Ireland Diagnostics Division Lisnamuck, Longford, Co. Longford, Ireland

Primary contact person for all communications:

Tracy Schmidt, Sr. Specialist, Regulatory Affairs Abbott Diagnostics Division Phone [phone] Fax [phone]

Secondary contact person for all communications:

Elizabeth Molina Campos, Project Manager, Regulatory Affairs Abbott Diagnostics Division Phone [phone] Fax [phone]

Date Summary Prepared: June 22, 2022.

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# III. Device Name

Cholesterol2

Reagents

Trade Name: Cholesterol2 Device Classification: Class I, meets the limitation of exemption per 21 CFR §862.9(c)(4) Classification Name: Enzymatic esterase--oxidase, cholesterol Governing Regulation Number: 21 CFR §862.1175 Product Code: CHH

# IV. Predicate Device

Cholesterol (k981652)

# V. Description of Device

# A. Principles of the Procedure

Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide oxidatively couples with N,N-Bis(4-sulfobutyl)-3-methylaniline (TODB) and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which is quantitated at 604 nm.

Methodology: Enzymatic

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# B. Reagents

The configurations of the Cholesterol2 reagent kits are described below.

Volumes (mL) listed in the following table indicate the volume per cartridge.

| | List Number | |
|------------------------------|-------------|---------|
| | 04S9220 | 04S9230 |
| Tests per cartridge | 250 | 800 |
| Number of cartridges per kit | 4 | 4 |
| Tests per kit | 1000 | 3200 |
| Reagent 1 (R1) | 21.6 mL | 62.5 mL |

Active ingredients: cholesterol esterase 0.880 KU/L, cholesterol oxidase Reagent 1: (CONII-FD) 0.330 KU/L, TODB 0.466 g/L, 4-aminoantipyrine 0.134 g/L and peroxidase (POD) 6.600 KU/L. Preservative: sodium azide.

The Cholesterol2 reagent is certified to be traceable to the National Reference System for cholesterol, against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN).

# VI. Intended Use of the Device

The Cholesterol2 assay is used for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System.

The Cholesterol2 assay is to be used as an aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

# VII. Comparison of Technological Characteristics

The Cholesterol2 assay (subject device) is an automated clinical chemistry assay for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System.

The similarities and differences between the subject assay and the predicate device are presented in the following table.

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| Characteristics | Subject Device<br>Cholesterol2 (List No. 04S92) | Predicate Device<br>Cholesterol (k981652; List No. 7D62) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platform | ARCHITECT c8000 System | Same* |
| Intended Use and<br>Indications for<br>Use | The Cholesterol2 assay is used for the<br>quantitation of cholesterol in human<br>serum or plasma on the<br>ARCHITECT c System.<br>The Cholesterol2 assay is to be used<br>as an aid in the diagnosis and<br>treatment of disorders involving<br>excess cholesterol in the blood and<br>lipid and lipoprotein metabolism<br>disorders. | The Cholesterol assay is used for the<br>quantitation of cholesterol in human<br>serum or plasma.<br>Cholesterol measurements are used in<br>the diagnosis and treatment of disorders<br>involving excess cholesterol in the<br>blood and lipid and lipoprotein<br>metabolism disorders. |
| Methodology | Enzymatic | Same |
| Specimen Type | Human serum or plasma | Same |
| Assay Principle/<br>Principle of<br>Procedure | Cholesterol esters are enzymatically<br>hydrolyzed by cholesterol esterase to<br>cholesterol and free fatty acids. Free<br>cholesterol, including that originally<br>present, is then oxidized by<br>cholesterol oxidase to cholest-4-ene-<br>3-one and hydrogen peroxide. The<br>hydrogen peroxide oxidatively<br>couples with N,N-Bis(4-sulfobutyl)-<br>3-methylaniline (TODB) and<br>4-aminoantipyrine to form a<br>chromophore (quinoneimine dye)<br>which is quantitated at 604 nm. | Cholesterol esters are enzymatically<br>hydrolyzed by cholesterol esterase to<br>cholesterol and free fatty acids. Free<br>cholesterol, including that originally<br>present, is then oxidized by cholesterol<br>oxidase to cholest-4-ene-3-one and<br>hydrogen peroxide. The hydrogen<br>peroxide combines with<br>hydroxybenzoic acid (HBA) and<br>4-aminoantipyrine to form a<br>chromophore (quinoneimine dye) which<br>is quantitated at 500 nm. |
| Standardization | Human cholesterol (Abell-Kendall) | Same |
| Use of Calibrators | Yes | Same |
| Use of Controls | Yes | Same |
| Assay Range | Analytical Measuring Interval (AMI):<br>5-748 mg/dL<br>Extended Measuring Interval (EMI):<br>748-2992 mg/dL<br>Reportable Interval:<br>2-2992 mg/dL | AMI: 7-705 mg/dL<br>EMI: 705-2820 mg/dL |
| Characteristics | Subject Device<br>Cholesterol2 (List No. 04S92) | Predicate Device<br>Cholesterol (k981652; List No. 7D62) |
| Platform | ARCHITECT c8000 System | Same* |
| Precision | Samples with cholesterol<br>concentrations between 21 and<br>718 mg/dL demonstrated standard<br>deviations ranging from 0.7 to<br>6.9 mg/dL and % Coefficient of<br>Variation (%CV) values ranging from<br>0.7 to 4.1%. | Samples with cholesterol concentrations<br>between 129.2 and 261.4 mg/dL<br>demonstrated standard deviations<br>ranging from 2.09 to 4.03 mg/dL and<br>% Coefficient of Variation (%CV)<br>values ranging from 1.5 to 1.6%. |
| Lower Limits of<br>Measurement | Limit of Blank: 0 mg/dL<br>Limit of Detection: 2 mg/dL<br>Limit of Quantitation: 5 mg/dL | Limit of Detection: 5.0 mg/dL<br>Limit of Quantitation: 6.2 mg/dL |
| Tube Types | Serum:<br>- Serum tubes<br>- Serum separator tubes<br><br>Plasma:<br>- Lithium heparin tubes<br>- Lithium heparin separator tubes<br>- Sodium heparin tubes | Serum:<br>Glass or plastic serum tubes with or<br>without gel barriers<br><br>Plasma:<br>Glass or plastic tubes<br>- Lithium heparin tubes (with or without<br>gel barrier)<br>- Sodium heparin tubes |

# Comparison of Subject Device Cholesterol2 to Predicate Device Cholesterol

In accordance with FDA Guidance Document "Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagent for Automated Analyzers", issued June 10, 1996, the assay equivalency study on ARCHITECT c System vs. the original platform, AEROSET, was performed and submitted under K980367/A004 in May 2002.

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# VIII. Summary of Nonclinical Performance

All performance characteristics were obtained using the ARCHITECT c8000 System.

# A. Reportable Interval

Based on the limit of detection (LoD), limit of quantitation (LoQ), precision, and linearity, the ranges over which results can be reported are provided below according to the definitions from CLSI EP34, 1st ed.*

| | mg/dL |
|--------------------------------------|----------|
| Analytical Measuring Interval (AMI)a | 5–748 |
| Extended Measuring Interval (EMI)b | 748–2992 |

^&quot; Clinical and Laboratory Standards Institute (CLS). Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking. 1st ed. CLSI Document EP34. Wayne, PA: CLSI; 2018.

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a AMI: The AMI extends from the LoQ to the upper limit of quantitation (ULoQ). This is determined by the range of values in mg/dL that demonstrated acceptable performance for linearity, imprecision, and bias.

b EMI: The EMI extends from the ULoQ to the ULoQ x sample dilution.

C The reportable interval extends from the LoD to the upper limit of the EMI.

NOTE: The default Low Linearity value of the assay file corresponds to the lower limit of the analytical measuring interval. Samples with cholesterol values below 5 mg/dL are reported as "< 5 mg/dL".

#### B. Within-Laboratory Precision

A study was performed based on guidance from CLSI EP05-A3. Testing was conducted using 3 lots of the Cholesterol2 reagent, 3 lots of the Consolidated Chemistry Calibrator, and 1 lot of commercially available controls and 3 instruments. Two controls and 3 human serum panels were tested in duplicate, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations, where a unique reagent lot and a unique calibrator lot is paired with 1 instrument. The performance from a representative combination is shown in the following table.

| | | | Within-Run<br>(Repeatability) | | Within-Laboratorya | |
|-----------------|----|-----------------|-------------------------------|-----|--------------------|------------------|
| Sample | n | Mean<br>(mg/dL) | SD | %CV | SD<br>(Rangeb) | %CV<br>(Rangeb) |
| Control Level 1 | 80 | 251 | 1.9 | 0.7 | 2.6<br>(2.6-3.1) | 1.0<br>(1.0-1.2) |
| Control Level 2 | 80 | 106 | 1.0 | 1.0 | 1.3<br>(1.3-1.7) | 1.2<br>(1.2-1.6) |
| Panel A | 80 | 21 | 0.6 | 3.0 | 0.8<br>(0.7-0.8) | 4.0<br>(3.2-4.1) |
| Panel B | 80 | 237 | 2.8 | 1.2 | 4.5<br>(3.7-4.9) | 1.9<br>(1.5-2.0) |
| Panel C | 80 | 718 | 6.4 | 0.9 | 6.6<br>(4.6-6.9) | 0.9<br>(0.7-1.0) |

ª Includes within-run, between-run, and between-day variability.

b Minimum and maximum SD or %CV across all reagent lot and instrument combinations.

Clinical and Laboratory Standards Institute (CLS). Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition. CLSI Document EP05-A3. Wayne, PA: CLSI; 2014.

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#### C. Lower Limits of Measurement

A study was performed based on guidance from CLSI EP17-A2. Testing was conducted using 3 lots of the Cholesterol2 reagent on each of 2 instruments over a minimum of 3 days. The maximum observed limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) values are summarized below.

| | mg/dL |
|------|-------|
| LoBa | 0 |
| LoDb | 2 |
| LoQc | 5 |

a The LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.

b The LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.

6 The LoQ is defined as the lowest concentration at which a maximum allowable precision of 20 %CV was met and was determined from n ≥ 60 replicates of low-analyte level samples.

### D. Linearity

A study was performed based on guidance from CLSI EP06-A.*

The assay was demonstrated to be linear across the analytical measuring interval of 5 to 748 mg/dL.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Detection Capability for Clinical Laboratory Measurent Procedures; Approved Guideline-Second Edition. CLSI Document EP17-A2. Wayne, PA: CLSI; 2012.

^* Clinical and Laboratory Standards Institute (CLS). Evaluation of the Linearity of Quanitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI Document EP06-A. Wayne, PA: CLSI; 2003.

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# E. Potentially Interfering Endogenous and Exogenous Substances

### Potentially Interfering Endogenous Substances

A study was performed based on guidance from CLSI EP07, 3rd ed. * Each substance was tested at 2 levels of the analyte (approximately 150 mg/dL and 220 mg/dL). No significant interference (interference within ± 10%, based on 95% confidence intervals) was observed at the following concentrations.

| Potentially Interfering Substance | Interferent Level |
|-----------------------------------|-------------------|
| Conjugated Bilirubin | 7 mg/dL |
| Unconjugated Bilirubin | 11 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Total protein | 15 g/dL |

Interference beyond ± 10% (based on 95% Confidence Intervals [CI]) was observed at the concentrations shown below for the following substance.

| Potentially Interfering<br>Substance | Interferent Level | Analyte Level | % Interference<br>(95% CI) |
|--------------------------------------|-------------------|---------------|----------------------------|
| Conjugated Bilirubin | 40 mg/dL | 150 mg/dL | -39%<br>(-40%, -39%) |
| Conjugated Bilirubin | 40 mg/dL | 220 mg/dL | -31%<br>(-31%, -30%) |
| Unconjugated Bilirubin | 16 mg/dL | 150 mg/dL | -11%<br>(-11%, -10%) |

Clinical and Laboratory Standards Institute (CLS). Interference Testing in Clinical Chemistry. 3rd ed. CLSI Guideline EP07. Wayne, PA: CLSI; 2018.

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# Potentially Interfering Exogenous Substances

# No significant interference (interference within ± 10%, based on 95% confidence intervals) was observed at the following concentrations.

| Potentially Interfering Substance | Interferent Level |
|-----------------------------------|-------------------|
| Acetaminophen | 160 mg/L |
| Acetylcysteine | 150 mg/L |
| Acetylsalicylic acid | 30 mg/L |
| Aminoantipyrine | 40 mg/L |
| Ampicillin-Na | 80 mg/L |
| Ascorbic acid | 55 mg/L |
| Biotin | 4250 ng/mL |
| Ca-dobesilate | 60 mg/L |
| Cefotaxime | 53 mg/dL |
| Cefoxitin | 6600 mg/L |
| Cyclosporine | 2 mg/L |
| Desacetylcefotaxime | 6 mg/dL |
| Dipyrone | 100 mg/L |
| Dobutamine | 0.2 mg/dL |
| Doxycycline | 20 mg/L |
| Ibuprofen | 220 mg/L |
| Intralipid | 1050 mg/dL |

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| Potentially Interfering Substance | Interferent Level |
|-------------------------------------|-------------------|
| Levodopa | 8 mg/L |
| Methotrexate | 140 mg/dL |
| Metronidazole | 130 mg/L |
| Methylaminoantipyrine | 40 mg/L |
| Methyldopa | 20 mg/L |
| N-Acetyl-p-benzoquinone (NAPQI) | 20 mg/L |
| Phenylbutazone | 330 mg/L |
| Phenytoin | 6 mg/dL |
| Rifampicin | 50 mg/L |
| Sodium heparin | 4 U/mL |
| Sulpiride | 15 mg/L |
| Theophylline (1,3-dimethylxanthine) | 60 mg/L |

Interference beyond ± 10% (based on 95% Confidence Intervals [CI]) was observed at the concentrations below for the following substance.

| Potentially Interfering<br>Substance | Interferent Level | Analyte Level | % Interference<br>(95% CI) |
|--------------------------------------|-------------------|---------------|----------------------------|
| Ascorbic acid | 60 mg/L | 150 mg/dL | -10%<br>(-11%, -10%) |
| Intralipid | 2000 mg/dL | 150 mg/dL | -27%<br>(-27%, -28%) |
| Intralipid | 2000 mg/dL | 220 mg/dL | -22%<br>(-21%, -23%) |
| Methyldopa | 30 mg/L | 150 mg/dL | -14%<br>(-14%, -13%) |

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# F. Method Comparison

A study was performed based on guidance from CLSI EP09-A3* using the Passing-Bablok regression method. The study compared the Cholesterol2 assay to the Cholesterol assay (List Number 7D62).

| Cholesterol2 vs. Cholesterol on the ARCHITECT c8000 System | | | | | | |
|------------------------------------------------------------|-------|-----|----------------------------|-----------|-------|------------------------|
| | Units | n | Correlation<br>Coefficient | Intercept | Slope | Concentration<br>Range |
| Serum | mg/dL | 138 | 1.00 | 0.41 | 0.98 | 7-684 |

# G. Tube Type

A study was performed to evaluate the suitability of specific blood collection tube types for use with the Cholesterol2 assay. Samples were collected from a minimum of 40 donors and evaluated across tube types. The following blood collection tube types were determined to be acceptable for use with the Cholestero12 assay:

Serum tubes Serum separator tubes Lithium heparin tubes Lithium heparin separator tubes Sodium heparin tubes

Clinical and Laboratory Standards Institute (CLS). Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition. CLSI Document EP09-A3. Wayne, PA: CLSI; 2013.

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### H. Dilution Verification

A study was performed to evaluate the performance of the Cholesterol2 automated dilution protocol and the manual dilution procedure on the ARCHITECT c8000 System.

Eight human serum samples were created by spiking cholesterol stock solution into SeraSub (a synthetic serum) to target concentrations across the extended measuring interval (EMI) (805, 1000, 1250, 1500, 1800, 2000, 2500, and 2800 mg/dL) that were value assigned using the analytically validated method.

The automated dilution factor for the Cholestero12 assay is 1:5.97.

The manual dilution factor of 1:4 was evaluated for the Cholesterol2 assay.

# I. Certificate of Traceability

The Cholesterol2 reagent is certified to be traceable to the National Reference System for Cholesterol, against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN).

# IX. Summary of Clinical Performance

This section does not apply.

# X. Conclusion Drawn from Nonclinical Laboratory Studies

The results presented in this 510(k) premarket notification demonstrate that the performance of the subject device. Cholesterol2 (List No. 04S92), is substantially equivalent to the predicate device, Cholesterol (List No. 7D62, k981652).

The similarities and differences between the subject device and predicate device are presented in Section 5-VII.

There is no known potential adverse effect to the operator when using this in vitro device according to the Cholesterol2 reagent package insert instructions.