(568 days)
Not Found
No
The description details a standard enzymatic clinical chemistry assay for cholesterol quantitation, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic assay used for the quantitation of cholesterol to aid in diagnosis and treatment, but it does not directly perform a therapeutic function on a patient.
Yes
The device is described as an aid in the diagnosis and treatment of disorders involving excess cholesterol and lipid and lipoprotein metabolism disorders, indicating its use in identifying or confirming the presence of medical conditions.
No
The device is an in vitro diagnostic assay, which is a chemical reagent kit used on a specific hardware system (ARCHITECT c System) to measure cholesterol levels. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitation of cholesterol in human serum or plasma. This is a key characteristic of an in vitro diagnostic device, as it analyzes biological samples taken from the human body.
- Device Description: The description details a chemical process that occurs outside the body (in vitro) to measure cholesterol levels. It describes enzymatic reactions and the formation of a chromophore that is then quantitated.
- Performance Studies: The performance studies describe the evaluation of the assay's performance using samples (serum and plasma), which is typical for IVD validation.
- Predicate Device: The mention of a "Predicate Device" with a K number (K981652) is a strong indicator that this device has gone through the FDA's 510(k) clearance process, which is the regulatory pathway for many IVD devices.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
CHH
Device Description
The Cholesterol2 assay is an automated clinical chemistry assay. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Within-Laboratory Precision Study:
- Study Type: Precision study based on CLSI EP05-A3 guidance.
- Sample Size: 80 replicates for each sample type.
- Key Results:
- Control Level 1 (Mean 251 mg/dL): SD 1.9, %CV 0.7 (Within-Run); SD 2.6, %CV 1.0 (Within-Laboratory).
- Control Level 2 (Mean 106 mg/dL): SD 1.0, %CV 1.0 (Within-Run); SD 1.3, %CV 1.2 (Within-Laboratory).
- Panel A (Mean 21 mg/dL): SD 0.6, %CV 3.0 (Within-Run); SD 0.8, %CV 4.0 (Within-Laboratory).
- Panel B (Mean 237 mg/dL): SD 2.8, %CV 1.2 (Within-Run); SD 4.5, %CV 1.9 (Within-Laboratory).
- Panel C (Mean 718 mg/dL): SD 6.4, %CV 0.9 (Within-Run); SD 6.6, %CV 0.9 (Within-Laboratory).
Lower Limits of Measurement Study:
- Study Type: Evaluation of detection capability based on CLSI EP17-A2 guidance.
- Sample Size: n ≥ 60 replicates for LoB, LoD, and LoQ.
- Key Results:
- LoB: 0 mg/dL
- LoD: 2 mg/dL
- LoQ: 5 mg/dL
Linearity Study:
- Study Type: Linearity evaluation based on CLSI EP06-A.
- Key Results: The assay demonstrated linearity across the analytical measuring interval of 5 to 748 mg/dL.
Potentially Interfering Endogenous Substances Study:
- Study Type: Interference testing based on CLSI EP07, 3rd ed.
- Key Results:
- No significant interference (within ± 10%) observed for: Conjugated Bilirubin (7 mg/dL), Unconjugated Bilirubin (11 mg/dL), Hemoglobin (1000 mg/dL), Total protein (15 g/dL).
- Interference beyond ± 10% observed for: Conjugated Bilirubin (40 mg/dL), Unconjugated Bilirubin (16 mg/dL).
Potentially Interfering Exogenous Substances Study:
- Key Results:
- No significant interference (within ± 10%) observed for a wide range of substances including Acetaminophen, Acetylcysteine, Acetylsalicylic acid, Aminoantipyrine, Ampicillin-Na, Biotin, Ca-dobesilate, Cefotaxime, Cefoxitin, Cyclosporine, Desacetylcefotaxime, Dipyrone, Dobutamine, Doxycycline, Ibuprofen, Intralipid (1050 mg/dL), Levodopa, Methotrexate, Metronidazole, Methylaminoantipyrine, N-Acetyl-p-benzoquinone (NAPQI), Phenylbutazone, Phenytoin, Rifampicin, Sodium heparin, Sulpiride, Theophylline.
- Interference beyond ± 10% observed for: Ascorbic acid (60 mg/L), Intralipid (2000 mg/dL), Methyldopa (30 mg/L).
Method Comparison Study:
- Study Type: Method comparison using Passing-Bablok regression method, based on CLSI EP09-A3.
- Sample Size: 138 (for Serum).
- Key Results:
- Serum: Correlation Coefficient 1.00, Intercept 0.41, Slope 0.98. Concentration Range 7-684 mg/dL.
Tube Type Study:
- Study Type: Evaluation of suitability of various blood collection tube types.
- Sample Size: Minimum of 40 donors.
- Key Results: Serum tubes, Serum separator tubes, Lithium heparin tubes, Lithium heparin separator tubes, and Sodium heparin tubes were determined to be acceptable.
Dilution Verification Study:
- Study Type: Evaluation of automated and manual dilution protocols.
- Key Results: Automated dilution factor 1:5.97, manual dilution factor 1:4 was evaluated.
Key Metrics
Analytical Measuring Interval (AMI): 5-748 mg/dL
Extended Measuring Interval (EMI): 748-2992 mg/dL
Reportable Interval: 2-2992 mg/dL
Limit of Blank (LoB): 0 mg/dL
Limit of Detection (LoD): 2 mg/dL
Limit of Quantitation (LoQ): 5 mg/dL
Precision (Within-Laboratory %CV):
- Control Level 1: 1.0%
- Control Level 2: 1.2%
- Panel A: 4.0%
- Panel B: 1.9%
- Panel C: 0.9%
Interference:
- Endogenous:
- Conjugated Bilirubin (40 mg/dL): -39% (95% CI: -40%, -39%) at 150 mg/dL analyte level; -31% (95% CI: -31%, -30%) at 220 mg/dL analyte level.
- Unconjugated Bilirubin (16 mg/dL): -11% (95% CI: -11%, -10%) at 150 mg/dL analyte level.
- Exogenous:
- Ascorbic acid (60 mg/L): -10% (95% CI: -11%, -10%) at 150 mg/dL analyte level.
- Intralipid (2000 mg/dL): -27% (95% CI: -27%, -28%) at 150 mg/dL analyte level; -22% (95% CI: -21%, -23%) at 220 mg/dL analyte level.
- Methyldopa (30 mg/L): -14% (95% CI: -14%, -13%) at 150 mg/dL analyte level.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1175 Cholesterol (total) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
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 (224) 668-2833 Fax (224) 668-0194
Secondary contact person for all communications:
Elizabeth Molina Campos, Project Manager, Regulatory Affairs Abbott Diagnostics Division Phone (224) 667-0037 Fax (224) 668-0194
Date Summary Prepared: June 22, 2022.
4
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
Cholesterol2 (List No. 04S92) | Predicate Device
Cholesterol (K981652; List No. 7D62) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Platform | ARCHITECT c8000 System | Same* |
| Intended Use and
Indications for
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. | The Cholesterol assay is used for the
quantitation of cholesterol in human
serum or plasma.
Cholesterol measurements are used in
the diagnosis and treatment of disorders
involving excess cholesterol in the
blood and lipid and lipoprotein
metabolism disorders. |
| Methodology | Enzymatic | Same |
| Specimen Type | Human serum or plasma | Same |
| Assay Principle/
Principle of
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. | 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 combines with
hydroxybenzoic acid (HBA) and
4-aminoantipyrine to form a
chromophore (quinoneimine dye) which
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):
5-748 mg/dL
Extended Measuring Interval (EMI):
748-2992 mg/dL
Reportable Interval:
2-2992 mg/dL | AMI: 7-705 mg/dL
EMI: 705-2820 mg/dL |
| Characteristics | Subject Device
Cholesterol2 (List No. 04S92) | Predicate Device
Cholesterol (K981652; List No. 7D62) |
| Platform | ARCHITECT c8000 System | Same* |
| Precision | Samples with cholesterol
concentrations between 21 and
718 mg/dL demonstrated standard
deviations ranging from 0.7 to
6.9 mg/dL and % Coefficient of
Variation (%CV) values ranging from
0.7 to 4.1%. | Samples with cholesterol concentrations
between 129.2 and 261.4 mg/dL
demonstrated standard deviations
ranging from 2.09 to 4.03 mg/dL and
% Coefficient of Variation (%CV)
values ranging from 1.5 to 1.6%. |
| Lower Limits of
Measurement | Limit of Blank: 0 mg/dL
Limit of Detection: 2 mg/dL
Limit of Quantitation: 5 mg/dL | Limit of Detection: 5.0 mg/dL
Limit of Quantitation: 6.2 mg/dL |
| Tube Types | Serum:
- Serum tubes
- Serum separator tubes
Plasma:
- Lithium heparin tubes
- Lithium heparin separator tubes
- Sodium heparin tubes | Serum:
Glass or plastic serum tubes with or
without gel barriers
Plasma:
Glass or plastic tubes
- Lithium heparin tubes (with or without
gel barrier) - 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 |
" 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.
8
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 "* 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
Substance | Interferent Level | Analyte Level | % Interference
(95% CI) |
|--------------------------------------|-------------------|---------------|----------------------------|
| Conjugated Bilirubin | 40 mg/dL | 150 mg/dL | -39%
(-40%, -39%) |
| Conjugated Bilirubin | 40 mg/dL | 220 mg/dL | -31%
(-31%, -30%) |
| Unconjugated Bilirubin | 16 mg/dL | 150 mg/dL | -11%
(-11%, -10%) |
Clinical and Laboratory Standards Institute (CLS). Interference Testing in Clinical Chemistry. 3rd ed. CLSI Guideline EP07. Wayne, PA: CLSI; 2018.
11
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
Substance | Interferent Level | Analyte Level | % Interference
(95% CI) |
|--------------------------------------|-------------------|---------------|----------------------------|
| Ascorbic acid | 60 mg/L | 150 mg/dL | -10%
(-11%, -10%) |
| Intralipid | 2000 mg/dL | 150 mg/dL | -27%
(-27%, -28%) |
| Intralipid | 2000 mg/dL | 220 mg/dL | -22%
(-21%, -23%) |
| Methyldopa | 30 mg/L | 150 mg/dL | -14%
(-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 | ||||
| Coefficient | Intercept | Slope | Concentration | |||
| 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.