(246 days)
The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
For use in clinical laboratories and point of care laboratory settings.
For prescription use only.
Afinion™ Lipid Panel is a fully automated assay for quantitative determination of Chol. HDL and Trig in serum. LDL, non- HDL and Chol/HDL are calculated by the Afinion™ AS100 Analyzer.
The Afinion™ Lipid Panel Test Cartridge contains all reagents necessary for determination of Chol, HDL and Trig in serum. The sampling device integrated in the test cartridge is filled with sample material. The test cartridge is then placed in the Afinion™ AS100 Analyzer. The analyzer inspects the sampling device, and the sample is then diluted.
Total Cholesterol (Chol) is measured by an enzymatic colorimetric method.
Triglycerides (Trig) are measured by an enzymatic colorimetric method.
HDL cholesterol is measured by an enzymatic colorimetric method with direct determination of HDL by initial antibody blocking of apolipoprotein B (apo-B).
LDL cholesterol is calculated by use of the Friedwald formula: LDL (mg/dL) = Chol - HDL - Trig/5.
non-HDL cholesterol is calculated as total cholesterol minus HDL: non-HDL = Chol - HDL.
Chol/HDL ratio is calculated as Total Cholesterol/ HDL Cholesterol.
Acceptance Criteria and Device Performance for Afinion™ Lipid Panel
This document outlines the acceptance criteria and the study that demonstrates the Afinion™ Lipid Panel's performance, as derived from the provided 510(k) summary (K132031).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria values for bias, precision (repeatability and within-device), or linearity. Instead, it presents the results of these studies and implies that these results were considered acceptable for demonstrating substantial equivalence to predicate devices. The reported device performance based on acceptable outcomes from comparison studies is presented below.
Interference: No significant interference (<10%) was observed from 26 common substances at specified concentrations. Limitations were noted for Calcium dobesilate, Methyldopa, Acetylcysteine, and Levodopa at certain levels.
Reporting Ranges (supported by linearity and LoQ studies):
| Analyte | Reportable Range (mg/dL) | Linearity Demonstrated (mg/dL) |
|---|---|---|
| Total Cholesterol | 100-500 | 77-511 |
| Triglycerides | 45-650 | 36-691 |
| HDL Cholesterol | 15-100 | 14-111 |
Accuracy (Method Comparison with Predicate Devices):
| Analyte | Intercept | Slope | Correlation Coefficient (r) |
|---|---|---|---|
| Chol | -4.5 mg/dL | 1.04 | 0.99 |
| Trig | -11.4 mg/dL | 1.04 | 1.00 |
| HDL | -2.1 mg/dL | 1.04 | 0.98 |
Bias at Medical Decision Levels (Implied Acceptance: Low Bias):
| Analyte | Concentration Level (mg/dL) | Bias (mg/dL) | Bias (%) |
|---|---|---|---|
| Trig | 150 | -5.0 | -3.3 |
| Trig | 200 | -2.8 | -1.4 |
| Trig | 500 | 9.9 | 2.0 |
| Chol | 200 | 2.6 | 1.3 |
| Chol | 240 | 4.0 | 1.7 |
| Chol | 400 | 9.7 | 2.4 |
| HDL | 40 | -0.6 | -1.6 |
| HDL | 60 | 0.1 | 0.1 |
| HDL | 80 | 0.8 | 1.0 |
Precision (Repeatability and Within-device %CV - Implied Acceptance: Low %CV):
Precision results are presented for control samples at two levels and one serum sample across three sites. The Coefficients of Variation (CV%) are generally low, indicating good precision. For example:
- Total Cholesterol: Repeatability CVs range from 1.7% to 3.5%, Within-device CVs range from 2.3% to 3.9%.
- HDL Cholesterol: Repeatability CVs range from 2.1% to 3.9%, Within-device CVs range from 2.6% to 4.9%.
- Triglycerides: Repeatability CVs range from 1.8% to 4.4%, Within-device CVs range from 2.2% to 4.9%.
2. Sample Sizes and Data Provenance
-
Linearity Testing:
- Test Set Sample Size: 11 concentration levels for each analyte, produced by intermixing one low and one high serum sample. Each level was measured in 4-6 replicates.
- Data Provenance: Not explicitly stated, but the studies were performed by the manufacturer, Axis-Shield PoC AS (located in Oslo, Norway). The samples were described as "serum samples." It's retrospective in the sense that it's test data generated for regulatory submission, but the samples themselves could have been collected prospectively or retrospectively.
-
Limits of Quantitation (LoQ) Testing:
- Test Set Sample Size: 5 samples with concentrations near 0 mg/dL (LoB samples) and 5 low concentration samples (LoD samples). Each sample was measured in a total of 60 replicates (likely 12 replicates per sample, using 3 analyzers and 2 test cartridge lots).
- Data Provenance: Not explicitly stated, but performed by the manufacturer. "Serum" is the sample type.
-
Analytical Specificity (Interference) Testing:
- Test Set Sample Size: "Samples covering two medical decision concentrations of each lipid analyte" were measured.
- Data Provenance: Not explicitly stated, but performed by the manufacturer.
-
Accuracy (Method Comparison) Testing:
- Test Set Sample Size:
- Cholesterol: 348 samples
- Triglycerides: 246 samples
- HDL: 251 samples
- Data Provenance: The study was "performed at four point-of-care sites." No specific country of origin is mentioned, but the manufacturer is based in Norway. The samples were "serum." The nature of sample collection (retrospective or prospective) is not specified.
- Test Set Sample Size:
-
Precision Testing:
- Test Set Sample Size: Two control samples and one serum sample were tested. For each sample, 80 replicates were performed at each of the three point-of-care sites (2 replicates per run, 2 runs per day for 20 days).
- Data Provenance: "Performed at three point-of-care sites." The origin of the control and serum samples is not detailed, but the study was conducted by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth
This device is an in vitro diagnostic (IVD) for quantitative determination of analytes in serum. The ground truth for such devices is established by reference methods or highly accurate laboratory methods, not by expert interpretation of images or clinical assessments.
- Traceability:
- Cholesterol (Chol) and HDL are traceable to the National Reference System for Cholesterol (NRS/CHOL).
- Triglycerides (Trig) are traceable to a Centers for Disease Control and Prevention (CDC) reference method.
- The device is CRMLN certified for Total Cholesterol and HDL Cholesterol, indicating its accuracy against reference measurement procedures.
Therefore, "experts" in the traditional sense (e.g., radiologists) are not used to establish ground truth for this type of device. The ground truth is established by recognized reference standards and methods in clinical chemistry.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments (e.g., image reading). This is a quantitative diagnostic device, and the ground truth is established by objective, highly accurate reference methods or laboratory instruments. Therefore, no "adjudication method" in this context is applicable or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting complex data (e.g., medical images). The Afinion™ Lipid Panel is a standalone quantitative measurement device, not an AI-assisted human reading system.
6. Standalone Performance Done
Yes, a standalone performance study was done. The studies detailed (linearity, limits of quantitation, analytical specificity, accuracy/method comparison, and precision) all represent the performance of the Afinion™ Lipid Panel device (algorithm only, without human-in-the-loop performance) in measuring lipid levels in serum samples.
7. Type of Ground Truth Used
The ground truth used is based on:
- Reference Methods: Specifically, the National Reference System for Cholesterol (NRS/CHOL) for Total Cholesterol and HDL Cholesterol, and a CDC reference method for Triglycerides.
- Comparison to Predicate Devices/Automated Laboratory Methods (CM): For accuracy evaluation, the Afinion™ Lipid Panel's results were compared against an "automated laboratory method (CM)" for Chol, Trig, and HDL, which are themselves established and validated lab instruments.
8. Sample Size for the Training Set
This document describes a 510(k) submission for an in vitro diagnostic device that measures specific analytes. It is highly unlikely that this device uses machine learning or AI models that require a "training set" in the conventional sense (i.e., iterative learning from labeled data). The device's operation is based on established enzymatic colorimetric methods and pre-programmed algorithms. Therefore, a "training set" size is not applicable or stated in this context.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, a "training set" as understood in machine learning is not applicable to this type of IVD device. The methods for establishing the device's accuracy and performance are described under "Traceability" and "Accuracy" (method comparison with reference and predicate methods).
{0}------------------------------------------------
27 February 2014
510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
510(k) SAFETY AND EFFECTIVENESS SUMMARY
This summary of 510(k) safety and efficacy information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K132031
| Submission type: | 510 (k) |
|---|---|
| Submitter/Owner: | Axis-Shield PoC ASVisiting address: Kjelsaasveien 161. N-0884 Oslo, NorwayPostal address: P.O. Box 6863 Rodelokka, N-0504 Oslo, Norway |
| Contact person: | Ms. Kari Skinnemoen, Regulatory Affairs ManagerE-mail: kaskin@axis-shield.com |
| Preparation date: | 21 June 2013 |
Device Name: Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
| Product code | Classification | Regulation Section | Panel |
|---|---|---|---|
| CHH - Total Cholesterol* | Class I | 21 CFR 862.1175 | 75-Chemistry |
| LBR – HDL Cholesterol* | Class I | 21 CFR 862.1475 | 75-Chemistry |
| JGY - Triglycerides* | Class I | 21 CFR 862.1705 | 75-Chemistry |
| JJX - Quality Control material* | Class I | 21 CFR 862.1660 | 75-Chemistry |
*Meets limitations of the exemption as per 21 CFR 862.9(c)(4).
Predicate Devices:
The predicate devices for Afinion™ Lipid Panel are the following legally marketed devices:
- . Total Cholesterol Roche Diagnostics Corp.: COBAS INTEGRA CHOLESTEROL GEN.2; Submission K031824
- . Triglycerides Roche Diagnostics Corp.: ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS); Submission K972250
- . HDL Cholesterol Siemens ADVIA 2400 Direct HDL Cholesterol; Submission K982341 (Original applicant: Randox laboratories, Ltd.)
{1}------------------------------------------------
Axis-Shield PoC AS 27 February 2014 510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
The predicate device for Afinion™ Lipid Panel Control is the following legally marketed device:
- Clinica Corp.: CLINIQA Liquid QC Lipid Controls Levels 1 and 2. Submission K061182 .
Intended use/Indications for use
The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
For use in clinical laboratories and point of care laboratory settings.
For prescription use only.
Principle of the assay
Afinion™ Lipid Panel is a fully automated assay for quantitative determination of Chol. HDL and Trig in serum. LDL, non- HDL and Chol/HDL are calculated by the Afinion™ AS100 Analyzer.
The Afinion™ Lipid Panel Test Cartridge contains all reagents necessary for determination of Chol, HDL and Trig in serum. The sampling device integrated in the test cartridge is filled with sample material. The test cartridge is then placed in the Afinion™ AS100 Analyzer. The analyzer inspects the sampling device, and the sample is then diluted.
Total Cholesterol (Chol)
Total Cholesterol is measured by an enzymatic colorimetric method. Esterified and free cholesterol are enzymatically converted into cholest-4-en-3-one and hydrogen peroxide. The hydrogen peroxide is used by hydrogen peroxidase to couple a phenol and 4-aminoantipyrin to a red quinoneimine dye. The color intensity is directly proportional to the concentration of free and esterified cholesterol in the sample.
Triglycerides (Trig)
Triglycerides are measured by an enzymatic colorimetric method. Triglycerides are enzymatically converted into glycerol by lipase. Glycerol is then further catalyzed in 2 steps to dihydroxy-acetone-phosphate and hydrogen peroxide. The hydrogen peroxide then reacts with 4aminophenazone and 4-chlorophenol under the action of peroxidase to form a red dyestuff. The
{2}------------------------------------------------
510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
color intensity is directly proportional to the concentration of triglycerides.
HDL cholesterol
In a first reaction, anti-human apolipoprotein B (apoB) antibody (R1) binds to apoB present on all lipoproteins but HDL (i.e. non-HDL). The antibody protects non-HDL from being degraded by pegylated cholesterol metabolizing enzymes in the second reaction (R2). In the R2 reaction free and esterified cholesterol of HDL are converted into cholest-4-en-3-one and hydrogen peroxide. The hydrogen peroxide is used by peroxidase to couple 4-aminoantipyrin to F-DAOS and forms a blue color complex. The color intensity is directly proportional to the concentration of free and esterified HDL cholesterol.
LDL cholesterol
NCEP recommends calculating LDL by use of the Friedwald formula": LDL (mg/dL) = Chol - HDL - Trig/5 This equation is not valid for non-fasting specimen, or in patients with type III hyperlipoproteinemia. No LDL result is provided by the analyzer when triglyceride levels are above 400 mg/dL as the Friedwald formula is less accurate at these triglyceride concentrations.
non-HDL cholesterol
The sum of VLDL (very low density lipoprotein) + LDL is called non-HDL cholesterol. It is calculated routinely as total cholesterol minus HDL: non-HDL = Chol - HDL
Chol/HDL ratio
Chol/HDL = Total Cholesterol/ HDL Cholesterol
Traceability of Afinion™ Lipid Panel
Chol and HDL are traceable to the National Reference System for Cholesterol (NRS/CHOL). Trig is traceable to a Centers for Disease Control and Prevention (CDC) reference method.
Afinion™ Lipid Panel is CRMLN certified for Total Cholesterol and HDL Cholesterol.
Afinion™ Lipid Panel Kit contents (per 15 tests unit)
- 15 Test Cartridges packaged separately in foil pouches .
- 1 Package Insert .
Materials required but not provided with the kit
- . Afinion™ AS100 Analyzer
- . Afinion™ Lipid Panel Control
- . Standard blood collection equipment
{3}------------------------------------------------
510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
Target value assignment and traceability of Afinion™ Lipid Panel Control
The Afinion™ Lipid Panel is used for target value assignment of the Afinion™ Lipid Panel Control C I and C II. The target values and the corresponding acceptable ranges printed in the labeling are derived from replicate analyses (n=18) and are specific for each lot of product. Testing is performed on one operating day using 3 or 6 analyzers. The tests are performed by the manufacturer using Afinion™ Lipid Panel test cartridges and a representative sampling of the control lot.
Chol and HDL are traceable to the National Reference System for Cholesterol (NRS/CHOL). Trig is traceable to a Centers for Disease Control and Prevention (CDC) reference method.
| Analyte | Target value range (mg/dL)Afinion™ Lipid Panel Control | |
|---|---|---|
| Control CI | Control CII | |
| Total cholesterol | 165-210 | 230-280 |
| HDL cholesterol | 34-46 | 52-70 |
| Triglycerides | 130-170 | 250-305 |
Estimated target values for Afinion™ Lipid Panel Control
Afinion™ Lipid Panel Control Stability
Real time stability studies were conducted to establish unopened and opened vial stability. Afinion™ Lipid Panel Control CI and CII were measured with the Afinion™ Lipid Panel assay. All results were compared to the initial baseline results.
The Afinion™ Lipid Panel Controls were continuously stored at 2-8 ℃ (36-46 °F). Testing was performed monthly for 12 months. The study is on-going.
Afinion™ Lipid Panel Control CI and CII were subjected to an opened vial (in-use) stressing study. The vials were stored at 2-8 ℃ (36-46 °F) in the periods between the test points. Testing was performed after 7, 14 and 30 days, and thereafter weekly until 8 weeks. In between these testing points the vials were opened and samples withdrawn twice a week.
The acceptance criteria for Total Cholesterol and Triglycerides were: Recovery to baseline within 100 ± 10 %.
The results from the stability studies support the following conclusions:
| Shelf life: | 12 months when stored refrigerated (2-8 °C, 36-46 °F) |
|---|---|
| Opened vials stability: | 8 weeks when stored refrigerated (2-8°C, 36-46 °F). |
{4}------------------------------------------------
| Characteristic | Roche DiagnosticsCorp.Cholesterol | Afinion™ Lipid PanelAnalyte: Total Cholesterol (Chol) |
|---|---|---|
| Intended use | Enzymatic in vitro testfor the directquantitativedetermination ofcholesterol in humanserum and plasma onRoche automaticclinical chemistryanalyzers | The Afinion™ Lipid Panel is an in vitrodiagnostic test for quantitative determination oftotal cholesterol (Chol), high-density lipoprotein(HDL) cholesterol and triglycerides (Trig) inserum. Values for low-density lipoprotein (LDL)cholesterol, non-HDL cholesterol and Chol/HDLratio are calculated by the Afinion™ AS100Analyzer. Chol, HDL cholesterol, Trig, andcalculated LDL cholesterol, non-HDLcholesterol and Chol/HDL ratio) are used in thediagnosis and treatment of disorders involvingexcess cholesterol in the blood and lipid andlipoprotein metabolism disorders.For use in clinical laboratories and point of carelaboratory settings. |
| Test principle | Enzymaticcolorimetric test | Enzymatic colorimetric test. |
| Specimen type | SerumPlasma | Serum |
| Reporting range | 3.86-800 mg/dL | 100-500 mg/dL |
| Calibration | Calibratedperiodically usingcalibrators supplied byvendor. | No calibration necessary by the user.Lot specific calibration via barcode on thecartridge. Calibration parameters are read by theanalyzer from the barcode before each run. |
| Sample volume | Sample isautomatically drawnfrom sample tube witha sample volume of atleast 0.5 mL. | 15 µL |
| Test time | 10 minutesBatch testing | 8 minutesSingle tests |
| Testingenvironment | For use by health careprofessionals.Laboratory testing onautomated clinicalchemistry analyzers(Hitachi) | For use by health care professionalsPoint of care testing using automated analyzer(Afinion™ AS100 Analyzer) |
| Assay reagents | Bottle of Reagent 1. | Ready to use test cartridges |
| Control material | 8 controls available | Afinion Lipid Panel Control: |
| available fromsupplier ofassay | Freeze-dried. | 2 control levels. Ready to use. |
| Reagents andcontrols storageconditions | Refrigerated storage,2-8 °C | Refrigerated storage, 2-8 °C |
Afinion™ Lipid Panel - Comparison of technological characteristics with predicate devices
{5}------------------------------------------------
| Characteristic | Roche DiagnosticsCorp.Triglycerides | Afinion™ Lipid PanelAnalyte: Triglycerides (Trig) |
|---|---|---|
| Intended use | Enzymatic in vitrotest for the directquantitativedetermination oftriglyceride inhuman serum andplasma on Rocheautomatic clinicalchemistry analyzers. | The Afinion™ Lipid Panel is an in vitro diagnostictest for quantitative determination of totalcholesterol (Chol), high-density lipoprotein (HDL)cholesterol and triglycerides (Trig) in serum. Valuesfor low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculatedby the Afinion™ AS100 Analyzer. Chol, HDLcholesterol, Trig, and calculated LDL cholesterol,non-HDL cholesterol and Chol/HDL ratio) are usedin the diagnosis and treatment of disorders involvingexcess cholesterol in the blood and lipid andlipoprotein metabolism disorders.For use in clinical laboratories and point of carelaboratory settings. |
| Test principle | Enzymaticcolorimetric test | Enzymatic colorimetric test. |
| Specimen type | SerumPlasma | Serum |
| Reportingrange | 8.85-885 mg/dL | 45-650 mg/dL |
| Calibration | Calibratedperiodically usingcalibrators suppliedby vendor. | No calibration necessary by the user.Lot specific calibration via barcode on the testcartridge. Calibration parameters are read by theanalyzer from the barcode before each run. |
| Samplevolume | Sample isautomatically drawnfrom sample tubewith a samplevolume of at least0.5 mL. | 15 μL |
| Test time | 5 minutesBatch testing | 8 minutesSingle tests |
{6}------------------------------------------------
Axis-Shield PoC AS 510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
| Testingenvironment | For use by healthcare professionals. | For use by health care professionals |
|---|---|---|
| Laboratory testingon automatedclinical chemistryanalyzers (Hitachi) | Point of care testing using automated analyzer(AfinionTM AS100 Analyzer) | |
| Assay reagents | Bottle of Reagent 1. | Ready to use test cartridges |
| Controlmaterialavailable fromsupplier of test | 8 controls available.Freeze-dried. | Afinion Lipid Panel Control:2 control levels. Ready to use. |
| Reagents andcontrolsstorageconditions | Refrigerated storage,2-8 °C | Refrigerated storage, 2-8 °C |
| Characteristic | Siemens ADVIA2400HDL-Cholesterol | Afinion™ Lipid PanelAnalyte: HDL Cholesterol |
|---|---|---|
| Intended use | For in vitrodiagnostic use in thequantitativedetermination ofHDL cholesterol inhuman serum andplasma on theADVIA Chemistrysystems. Suchmeasurements areused in the riskassessment ofcoronary arterydisease | The Afinion™ Lipid Panel is an in vitro diagnostictest for quantitative determination of totalcholesterol (Chol), high-density lipoprotein (HDL)cholesterol and triglycerides (Trig) in serum. Valuesfor low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculatedby the Afinion™ AS100 Analyzer. Chol, HDLcholesterol, Trig, and calculated LDL cholesterol,non-HDL cholesterol and Chol/HDL ratio) are usedin the diagnosis and treatment of disorders involvingexcess cholesterol in the blood and lipid andlipoprotein metabolism disorders.For use in clinical laboratories and point of carelaboratory settings. |
| Test principle | Enzymaticcolorimetric test.Direct determinationof HDL-cholesterol.Cholesterol fromnon-HDL particles iseliminated in thefirst reaction step. | Enzymatic colorimetric test.Direct determination of HDL by initial antibodyblocking of apolipoprotein B (apo-B) , which ispresent on all lipoproteins except HDL cholesterol. |
| Specimen type | SerumPlasma | Serum |
| Reportingrange | 5-115 mg/dL | 15-100 mg/dL |
| Calibration | Calibratedperiodically usingcalibrators suppliedby vendor. | No calibration necessary by the user.Lot specific calibration via barcode on the cartridge.Calibration parameters are read by the analyzerfrom the barcode before each run. |
| Samplevolume | Sample isautomatically drawnfrom sample tubewith a samplevolume of at least0.5 mL. | 15 µL |
| Test time | 10 minutesBatch testing | 8 minutesSingle tests |
| Testingenvironment | For use by healthcare professionals.Laboratory testingon automatedclinical chemistryanalyzers (ADVIA)) | For use by health care professionalsPoint of care testing using automated analyzer(Afinion™ AS100 Analyzer) |
| Assay reagents | Bottles of Reagent 1and Reagent 2 | Ready to use test cartridges |
| Storageconditions | Refrigerated storage,2-8 °C | Refrigerated storage, 2-8 °C |
| Controlmaterial | 2 control levelsrecommended.Available from Bio-Rad Laboratories | Afinion Lipid Panel Control:2 control levels. Ready to use. |
.
{7}------------------------------------------------
510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
{8}------------------------------------------------
Characteristic Cliniqa Liquid OC Lipid Afinion™ Lipid Panel Control Control Similarities Intended Use CLINIQA Liquid QC Lipid Afinion™ Lipid Panel Control is Control is intended for use as an intended for use as assaved control assayed quality control material for material for total cholesterol Apolipoprotein A-1, (Chol), high-density lipoprotein Apolipoprotein B, Cholesterol (HDL) cholesterol and (Total), High Density Lipoprotein, triglycerides (Trig). Low Density Lipoprotein and Triglycerides. Matrix Human serum Human serum* Analyte Total Cholesterol Total Cholesterol HDL Cholesterol HDL Cholesterol Triglycerides Triglycerides Liquid - ready to use Form Liquid - ready to use Levels 2 2 Storage 2-8°C 2-8°C conditions Differences Analytes Target values also available for No target values for ApoLipoprotein A1 and ApoLipoprotein A1 and Apolipoprotein B and LDL Apolipoprotein B as they are not Cholesterol. measured by Afinion™ Lipid Panel. LDL cholesterol is calculated by Afinion™ AS100 Analyzer, and no target value for LDL is assigned. Kit size 3 x 2 x 3 mL 2 x 1 x 1.0 mL or L1: 6 x 3 mL and L2: 6 x 3 mL Target value Target values are method Target values are assigned for assignment dependent, and assigned values are Afinion™ Lipid Panel. available for a large number of methods/systems.
Afinion™ Lipid Panel Control - Comparison of technological characteristics with predicate device
- Each serum/plasma donor unit used in the manufacture of the control products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag.
{9}------------------------------------------------
Linearity
The Afinion™ Lipid Panel assay has been demonstrated to be linear across the measuring ranges according to CLSI Guideline EP6-A. The study was performed measuring dilution series with serum samples. One low and one high sample were intermixed to produce 11 concentration levels for each analyte. Each level was measured in 4-6 replicates. The linear regression lines for comparison of measured concentration (y) and theoretical concentration (x) are:
| Total cholesterol: | y=1.000x - 4.5 mg/dL, r2=0.995 |
|---|---|
| Triglycerides: | y=1.009x - 2.9 mg/dL, r2=0.999 |
| HDL Cholesterol: | y=0.991x - 2.4 mg/dL, r2=0.994 |
Linearity for Total Cholesterol, Triglycerides and HDL Cholesterol using serum samples has been demonstrated over the following ranges:
| Total cholesterol: | 77-511 mg/dL | (Reportable range 100-500 mg/dL) |
|---|---|---|
| Triglycerides: | 36-691 mg/dL | (Reportable range 45-650 mg/dL) |
| HDL Cholesterol: | 14-111 mg/dL | (Reportable range 15-100 mg/dL) |
Limits of Quantitation
Limits of quantitation have been established according to CLSI Guideline EP-17A, which determines Limits of quantitation (LoQ) based on determination of limits of blank (LoB) and Limits of Detection (LoD). 5 samples with concentration near 0 mg/dL (LoB samples) were measured in totally 60 replicates using 3 analyzers and 2 Afinion™ Lipid Panel test cartridge lots. 5 low concentration samples (LoD samples) were tested according to the same test scheme. LoQ was estimated based on the established LoD.
The following limits of quantitation have been established for Afinion™ Lipid Panel in serum:
| AnalvteMILLALLA-SE- | or a status and a control andotal Cholesterol | HDL Cholesterol | Triglvcerides | |
|---|---|---|---|---|
| By Antiques of the control concessions of the consideration(17る(mg/dLFOR AND ALL ALL ALL A LA--------------------------------------------------------------------- | 1 | A SHORIO A L'ANIEL LEDITOR A CONSULER1. | THE THE THE OF THE FELLER FREAL CALL CALL CALL CALL COLLECT COLLECTION COLLECTION OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF COLLECTION OF COL1 |
Analytical specificity
Design verification studies have been performed to investigate whether any endogenous and exogenous substances interfere with the Afinion™ Lipid Panel assay. The studies have been performed in accordance with CLSI guideline EP7-A2.
Interference effect from 28 substances has been evaluated, among commonly used antibiotics, statins, analgesic agents, immune-suppressants and anticoagulants. The substances tested are those previously assessed within the predicate devices, substances found to interfere with lipid tests based on a literature search. In addition the most common drugs used for lipid-lowering therapy and diabetic management have been tested.
{10}------------------------------------------------
The substances listed below were tested for interference with the measurements of Chol. HDL and Trig. Samples covering two medical decision concentrations of each lipid analyte were measured. No significant interference (<10%) was observed up to the following concentrations:
- Acetaminophen 200 mg/L .
- . Acetylsalicylic acid 1000 mg/L
- . Acetylcysteine 1590 mg/L
- Ampicillin 1000 mg/L .
- Ascorbic acid 6 mg/dL .
- . Atorvastatin 600 µg/L
- Bilirubin (conjugated and . unconjugated) 20 mg/dL
- Calcium dobesilate 0.7 mg/dL .
- . Cefoxitin 2500 mg/L
- . CyclosporineA 5mg/L
- . CyclosporineC 5mg/L
- Fluvastatin 2.97 mg/L .
- . Hemoglobin (hemolysis) 0.5 g/dL
- . Heparin 3000 U/L
- Ibuprofen 500 mg/L .
- . Intralipid 10000 mg/L
- Levodopa 15 mg/L .
- . Lovastatin 216 ug/L
- . Metformin 40 mg/L
- Methyldopa 1.4 mg/dL
- . Metronidazole 200 mg/L
- . Pravastatin 7.32 mg/L
- . Rifampicin 64.3 mg/L
- . Simvastatin 80.4 µg/L
- . Theophylline 100 mg/L
- Tetracycline 50 mg/L .
Limitations:
- Calcium dobesilate interferes with Afinion™ Lipid Panel at therapeutic levels and results in . falsely low results for Chol, HDL and Trig.
- . Methyldopa concentrations above 1.4 mg/dL interfere with Afinion™ Lipid Panel and may give falsely low Trig results. This is above toxic levels of Methyldopa and there is no interference at therapeutic levels.
- Acetylcysteine concentrations above 1590 mg/L may give falsely low Trig results. This is above the drug concentration at therapeutic level.
- Levodopa concentrations above 15 mg/L may give falsely low HDL and Trig results. This . is above the drug concentration at therapeutic level.
Accuracy
A method comparison was performed between Afinion™ Lipid Panel and automated laboratory methods (CM) for Chol, Trig and HDL. The study was performed at four point-of-care sites. The study was performed according to CLSI guideline EP09-A2-IR, except that single replicates per sample was used for the Afinion™ Lipid Panel measurements and not duplicates as stated in the guideline. Regression analysis results for each analyte in serum are summarized in table 1. Bias at medical decision levels and elevated concentration levels are summarized in table 2. Bland-Altman plots are presented in figures 1-3.
{11}------------------------------------------------
510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
| Analyte | Number ofsamples | Intercept | Slope | Correlationcoefficient (r) | Range |
|---|---|---|---|---|---|
| Chol | 348 | -4.5 mg/dL | 1.04 | 0.99 | 105.5 - 466.0 mg/dL |
| Trig | 246 | -11.4 mg/dL | 1.04 | 1.00 | 55.5-616.5 mg/dL |
| HDL | 251 | -2.1 mg/dL | 1.04 | 0.98 | 23.2-92.7 mg/dL |
Table 1 Method comparison results for serum.
Table 2 Calculated bias (in mg/dL and %) at different concentration levels for serum.
| Analyte | Concentrationlevel (mg/dL) | Bias(mg/dL) | Bias (%) |
|---|---|---|---|
| Trig | 150 | -5.0 | -3.3 |
| Trig | 200 | -2.8 | -1.4 |
| Trig | 500 | 9.9 | 2.0 |
| Chol | 200 | 2.6 | 1.3 |
| 240 | 4.0 | 1.7 | |
| 400 | 9.7 | 2.4 | |
| HDL | 40 | -0.6 | -1.6 |
| 60 | 0.1 | 0.1 | |
| 80 | 0.8 | 1.0 |
Bland-Altman of Total Cholesterol Serum
Image /page/11/Figure/8 description: This image is a scatter plot that compares the difference in cholesterol measurements between two methods, Afinion and CM, against the average of the two methods. The y-axis represents the difference in cholesterol levels (Afinion - CM) in mg/dL, ranging from -40 to 40. The x-axis represents the average cholesterol level in mg/dL, ranging from 100 to 500, with data points scattered around the zero difference line, indicating the agreement between the two methods.
Figure 1 Bland-Altman plot of total cholesterol, serum. Difference in mg/dL.
{12}------------------------------------------------
510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
Figure 2 Bland-Altman plot of HDL cholesterol, serum. Difference in mg/dL.
Image /page/12/Figure/5 description: This image is a Bland-Altman plot of triglycerides serum. The x-axis is labeled "Trig (mg/dL) (Average of Afinion and CM)" and ranges from 100 to 600. The y-axis is labeled "Difference Trig (mg/dL) (Afinion - CM)" and ranges from -60 to 60. There are many data points scattered around the plot, with most points falling between -20 and 20 on the y-axis.
Figure 3 Bland-Altman plot of Triglycerides, serum. Difference in mg/dL.
{13}------------------------------------------------
Axis-Shield PoC AS 27 February 2014 510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
Precision
Repeatability and within-device (total) precision were determined according to the CLSI Guideline EP5-A2. The precision study was performed at three point-of-care sites using one lot of Afinion™ Lipid Panel test cartridges and 2-3 analyzers per site.
Two controls and one serum sample were tested with 2 replicates per run and 2 runs per day for 20 days with a total of 80 replicates at each site. The results are summarized in tables 3-5.
| Site | N | Mean(mg/dL) | Repeatability | Within-device | |||
|---|---|---|---|---|---|---|---|
| SD(mg/dL) | CV (%) | SD(mg/dL) | CV (%) | ||||
| Control sample | 1 | 80 | 185.8 | 3.2 | 1.7 | 4.3 | 2.3 |
| Control sample | 2 | 80 | 186.5 | 5.5 | 2.9 | 6.7 | 3.6 |
| Control sample | 3 | 80 | 186.3 | 5.8 | 3.1 | 5.6 | 3.0 |
| Control sample | 1 | 80 | 249.2 | 6.3 | 2.5 | 6.1 | 2.4 |
| Control sample | 2 | 80 | 252.4 | 6.2 | 2.4 | 9.8 | 3.9 |
| Control sample | 3 | 80 | 249.3 | 8.9 | 3.5 | 8.5 | 3.4 |
| Serum sample | 1 | 80 | 400.0 | 7.0 | 1.7 | 9.4 | 2.3 |
| Serum sample | 2 | 80 | 401.4 | 10.2 | 2.5 | 12.4 | 3.1 |
| Serum sample | 3 | 80 | 401.4 | 9.6 | 2.4 | 11.1 | 2.8 |
Table 3: Cholesterol. Repeatability and Within-device precision (total), N=number of replicates, SD=Standard deviation, CV=Coefficient of Variation.
| Table 4: HDL. Repeatability and Within-device precision (total), N=number of replicates. |
|---|
| SD=Standard deviation, CV=Coefficient of Variation. |
| Site | N | Mean(mg/dL) | Repeatability | Within-device | |||
|---|---|---|---|---|---|---|---|
| SD(mg/dL) | CV (%) | SD(mg/dL) | CV (%) | ||||
| Control sample | 1 | 80 | 39.8 | 1.1 | 2.7 | 1.3 | 3.2 |
| Control sample | 2 | 80 | 40.6 | 1.6 | 3.9 | 2.0 | 4.9 |
| Control sample | 3 | 80 | 40.1 | 1.1 | 2.8 | 1.2 | 3.1 |
| Control sample | 1 | 80 | 57.1 | 1.4 | 2.5 | 1.6 | 2.8 |
| Control sample | 2 | 80 | 59.4 | 2.1 | 3.5 | 2.6 | 4.4 |
| Control sample | 3 | 80 | 57.9 | 2.1 | 3.6 | 2.1 | 3.6 |
| Serum sample | 1 | 80 | 70.8 | 1.8 | 2.5 | 1.8 | 2.6 |
| Serum sample | 2 | 80 | 72.8 | 1.6 | 2.2 | 3.0 | 4.1 |
| Serum sample | 3 | 80 | 72.0 | 1.5 | 2.1 | 1.9 | 2.6 |
{14}------------------------------------------------
510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
| Repeatability | Within-device | ||||||
|---|---|---|---|---|---|---|---|
| Site | N | Mean(mg/dL) | SD(mg/dL) | CV (%) | SD(mg/dL) | CV (%) | |
| Control sample | 1 | 80 | 153.8 | 3.6 | 2.3 | 4.1 | 2.7 |
| 2 | 80 | 154.5 | 3.9 | 2.5 | 5.4 | 3.5 | |
| 3 | 80 | 154.8 | 4.2 | 2.7 | 4.5 | 2.9 | |
| Control sample | 1 | 80 | 276.2 | 7.1 | 2.6 | 7.1 | 2.6 |
| 2 | 80 | 279.1 | 5.8 | 2.1 | 10.4 | 3.7 | |
| 3 | 80 | 276.0 | 12.2 | 4.4 | 13.4 | 4.9 | |
| Serum sample | 1 | 80 | 343.5 | 6.3 | 1.8 | 7.4 | 2.2 |
| 2 | 80 | 344.1 | 10.6 | 3.1 | 13.5 | 3.9 | |
| 3 | 80 | 343.3 | 9.3 | 2.7 | 12.3 | 3.6 |
Table 5: Triglycerides. Repeatability and Within-device precision (total), N=number of replicates, SD=Standard deviation, CV=Coefficient of Variation.
Conclusion
Comparison of information characterizing the Afinion Total Cholesterol, Triglyceride and HDL Cholesterol assays and the Afinion Lipid Panel controls for use on the Afinion AS 100 Analyzer including results of the method comparison, precision, sensitivity, specificity, bias, and linearity studies, as well as the value assignment and stability studies for the Lipid Panel controls showed the results to be substantially equivalent to the predicate devices.
{15}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2014
AXIS-SHIELD POC AS KARI SKINNEMOEN P.O. BOX 6863 RODELOKKA OSLO N-0504, NORWAY
Re: K132031 Trade/Device Name: Afinion™ Lipid Panel Afinion™ Lipid Panel Control Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: I, Meets limitations of the exemption as per 21 CFR 862.9(c)(4). Product Code: CHH, LBR, JGY, JJY Dated: February 10, 2014 Received: February 12, 2014
Dear Ms. Skinnemoen:
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. 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.
ff 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.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{16}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Couriney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{17}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
Indications for Use
510(k) Number (if known) K132031
Device Name
Afinion™ Lipid Panel and Afinion™ Lipid Panel Control
Indications for Use (Describe)
The Afinion™ Lipid Panel is an in viro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
For use in clinical laboratories and point of care laboratory settings.
For prescription use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . ..:
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ruth A. Chesler -S
§ 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.