Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard enzymatic colorimetric methods and simple mathematical calculations (Friedwald formula, subtraction, division) for determining lipid levels. There is no mention of AI or ML techniques.

Therapeutic

No
This device is an in vitro diagnostic test used for quantitative determination of lipid levels, which are then used in the diagnosis and treatment of disorders. It does not provide therapy itself but rather aids in diagnosis.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the test and its calculated values "are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders." This directly indicates its role as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical test cartridge containing reagents and a sampling device, which is inserted into an analyzer. This indicates a hardware component is integral to the device's function. While the analyzer performs calculations (which is software), the overall device system includes hardware.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The very first sentence explicitly states, "The Afinion™ Lipid Panel is an in vitro diagnostic test..." It also describes the quantitative determination of analytes (cholesterol, HDL, triglycerides) in a biological sample (serum) for use in the "diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders." This directly aligns with the definition of an IVD.
Device Description: The description details how the test works by analyzing a sample (serum) using reagents within a test cartridge to measure specific analytes. This is characteristic of an in vitro diagnostic device.
Control Material: The description of the Afinion™ Lipid Panel Control as "assayed control material" used to "confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results" is also consistent with the use of controls in IVD testing.
Care Setting: The intended use in "clinical laboratories and point of care laboratory settings" further supports its classification as an IVD, as these are typical environments where IVD tests are performed.
Prescription Use Only: This indicates that the device is intended for use under the supervision of a healthcare professional, which is common for IVD tests used in diagnosis and treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

CHH, LBR, JGY, JJX

Device Description

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 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 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 color intensity is directly proportional to the concentration of triglycerides.

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.

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

For use in clinical laboratories and point of care laboratory settings. For prescription use only.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
Linearity demonstrated over 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:
Established according to CLSI Guideline EP-17A. 5 samples with concentration near 0 mg/dL (LoB samples) were measured in 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 scheme.

Analytical specificity:
Design verification studies performed to investigate interference from 28 endogenous and exogenous substances, in accordance with CLSI guideline EP7-A2. Samples covering two medical decision concentrations were measured. No significant interference (

Regulation Number and Section

§ 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.

Summary

0

27 February 2014

510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control

K132031

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 AS
Visiting address: Kjelsaasveien 161. N-0884 Oslo, Norway
Postal address: P.O. Box 6863 Rodelokka, N-0504 Oslo, Norway
Contact person:	Ms. Kari Skinnemoen, Regulatory Affairs Manager
E-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 Diagnostics
Corp.
Cholesterol | Afinion™ Lipid Panel
Analyte: Total Cholesterol (Chol) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Enzymatic in vitro test
for the direct
quantitative
determination of
cholesterol in human
serum and plasma on
Roche automatic
clinical chemistry
analyzers | 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.
For use in clinical laboratories and point of care
laboratory settings. |
| Test principle | Enzymatic
colorimetric test | Enzymatic colorimetric test. |
| Specimen type | Serum
Plasma | Serum |
| Reporting range | 3.86-800 mg/dL | 100-500 mg/dL |
| Calibration | Calibrated
periodically using
calibrators supplied by
vendor. | No calibration necessary by the user.
Lot specific calibration via barcode on the
cartridge. Calibration parameters are read by the
analyzer from the barcode before each run. |
| Sample volume | Sample is
automatically drawn
from sample tube with
a sample volume of at
least 0.5 mL. | 15 µL |
| Test time | 10 minutes
Batch testing | 8 minutes
Single tests |
| Testing
environment | For use by health care
professionals.
Laboratory testing on
automated clinical
chemistry analyzers
(Hitachi) | For use by health care professionals
Point 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 from
supplier of
assay | Freeze-dried. | 2 control levels. Ready to use. |
| Reagents and
controls storage
conditions | Refrigerated storage,
2-8 °C | Refrigerated storage, 2-8 °C |

Afinion™ Lipid Panel - Comparison of technological characteristics with predicate devices

5

| Characteristic | Roche Diagnostics
Corp.
Triglycerides | Afinion™ Lipid Panel
Analyte: Triglycerides (Trig) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Enzymatic in vitro
test for the direct
quantitative
determination of
triglyceride in
human serum and
plasma on Roche
automatic clinical
chemistry analyzers. | 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.
For use in clinical laboratories and point of care
laboratory settings. |
| Test principle | Enzymatic
colorimetric test | Enzymatic colorimetric test. |
| Specimen type | Serum
Plasma | Serum |
| Reporting
range | 8.85-885 mg/dL | 45-650 mg/dL |
| Calibration | Calibrated
periodically using
calibrators supplied
by vendor. | No calibration necessary by the user.
Lot specific calibration via barcode on the test
cartridge. Calibration parameters are read by the
analyzer from the barcode before each run. |
| Sample
volume | Sample is
automatically drawn
from sample tube
with a sample
volume of at least
0.5 mL. | 15 μL |
| Test time | 5 minutes
Batch testing | 8 minutes
Single tests |

6

Axis-Shield PoC AS 510(k) Summary Afinion™ Lipid Panel and Afinion™ Lipid Panel Control

| Testing
environment | For use by health
care professionals. | For use by health care professionals |
|-----------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| | Laboratory testing
on automated
clinical chemistry
analyzers (Hitachi) | Point of care testing using automated analyzer
(AfinionTM AS100 Analyzer) |
| Assay reagents | Bottle of Reagent 1. | Ready to use test cartridges |
| Control
material
available from
supplier of test | 8 controls available.
Freeze-dried. | Afinion Lipid Panel Control:
2 control levels. Ready to use. |
| Reagents and
controls
storage
conditions | Refrigerated storage,
2-8 °C | Refrigerated storage, 2-8 °C |

| Characteristic | Siemens ADVIA
2400
HDL-Cholesterol | Afinion™ Lipid Panel
Analyte: HDL Cholesterol |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For in vitro
diagnostic use in the
quantitative
determination of
HDL cholesterol in
human serum and
plasma on the
ADVIA Chemistry
systems. Such
measurements are
used in the risk
assessment of
coronary artery
disease | 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.
For use in clinical laboratories and point of care
laboratory settings. |
| Test principle | Enzymatic
colorimetric test.
Direct determination
of HDL-cholesterol.
Cholesterol from
non-HDL particles is
eliminated in the
first reaction step. | Enzymatic colorimetric test.
Direct determination of HDL by initial antibody
blocking of apolipoprotein B (apo-B) , which is
present on all lipoproteins except HDL cholesterol. |
| | | |
| Specimen type | Serum
Plasma | Serum |
| Reporting
range | 5-115 mg/dL | 15-100 mg/dL |
| Calibration | Calibrated
periodically using
calibrators supplied
by vendor. | No calibration necessary by the user.
Lot specific calibration via barcode on the cartridge.
Calibration parameters are read by the analyzer
from the barcode before each run. |
| Sample
volume | Sample is
automatically drawn
from sample tube
with a sample
volume of at least
0.5 mL. | 15 µL |
| Test time | 10 minutes
Batch testing | 8 minutes
Single tests |
| Testing
environment | For use by health
care professionals.
Laboratory testing
on automated
clinical chemistry
analyzers (ADVIA)) | For use by health care professionals
Point of care testing using automated analyzer
(Afinion™ AS100 Analyzer) |
| Assay reagents | Bottles of Reagent 1
and Reagent 2 | Ready to use test cartridges |
| Storage
conditions | Refrigerated storage,
2-8 °C | Refrigerated storage, 2-8 °C |
| Control
material | 2 control levels
recommended.
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:

| Analvte
MILLALLA-SE- | or a status and a control and
otal Cholesterol | HDL Cholesterol | Triglvcerides | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| By Antiques of the control concessions of the consideration
(
17
る
(mg/dL
FOR AND ALL ALL ALL A LA
--------------------------------------------------------------------- | 1 | A SHORIO A L'ANIEL LEDITOR A CONSULER
1
. | 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 COL
1 | |

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 (