For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.

This in vitro diagnostic device is intended for prescription use only.

Device Description

The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312

R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Device Name: Direct LDL Cholesterol (LDL)

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (Implied/Direct)	Reported Device Performance
Precision	Total CV % (within run, among run, among day)	Generally expected to be low for clinical assays, with specific targets often dependent on concentration levels.	QC 1 (92.0 mg/dl): 5.9% total CV QC 2 (135.9 mg/dl): 4.6% total CV QC 3 (186.7 mg/dl): 4.4% total CV Serum pool 1 (65.0 mg/dl): 5.9% total CV Serum pool 2 (154.0 mg/dl): 5.0% total CV Serum pool 3 (200.1 mg/dl): 5.0% total CV Serum pool 4 (343.7 mg/dl): 5.3% total CV
Linearity/Reportable Range	Linear Regression Correlation Coefficient (r)	Close to 1.0 (indicating a strong linear relationship)	r = 0.997
	Reportable Range	Defined range where results are linear.	21 - 740 mg/dl
Detection Limit	Limit of Blank (LoB)	Very low, ideally close to zero, to ensure no signal from blank.	1.94 mg/dl
	Limit of Detection (LoD)	Low enough to reliably detect the analyte.	3.19 mg/dl
	Limit of Quantitation (LoQ)	Low enough for precise and accurate quantification at low concentrations (typically ≤20% imprecision).	16.1 mg/dl (with ≤20% imprecision)
Analytical Specificity	Interference (% of Control)	% of Control ± 10% for potential interferents at specified concentrations.	Hemoglobin: No significant interference up to 1000mg/dl.Total Bilirubin: No significant interference up to 60mg/dl.Conjugate Bilirubin: No significant interference up to 60mg/dl.Triglycerides: No significant interference up to 500mg/dl.Intralipid®: No significant interference up to 500mg/dl.Ascorbic Acid: No significant interference up to 6mg/dl.
Method Comparison	Linear Regression Correlation Coefficient (r)	Close to 1.0 when compared to a predicate device, indicating substantial equivalence.	r = 0.998 (compared to predicate device)
Matrix Comparison	Linear Regression Correlation Coefficient (r)	Close to 1.0 when comparing serum and lithium heparin plasma, indicating equivalent performance across matrices.	r = 0.998 (serum vs. lithium heparin plasma)
Traceability	Conformance to reference materials/standards	Traceable to an internal master reference material. Not certified by CRMLN (stated as a disclaimer in labeling).	Traceable to an internal master reference. Labeling states "device has not been certified by the CRMLN."

Study Details

Sample size used for the test set and the data provenance:
- Precision (Analytical Performance): 80 determinations for each of 7 pools/QC levels (total of 560 determinations). The samples included control material and "unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges" (e.g., <100mg/dl, 130-159mg/dL, etc.). Data provenance is unspecified, but implied to be from a laboratory setting (prospective testing) rather than patient cohorts, using human serum.
- Linearity/Assay Reportable Range: 11 levels, run in replicates of five on two lots of reagent. This means 11 * 5 * 2 = 110 individual measurements. The samples were prepared using "low and high serum pools." Data provenance is unspecified, but implied to be laboratory-prepared (prospective testing) using serum.
- Detection Limit: 240 determinations (across 4 low-level samples) for LoD. Data provenance is unspecified, but implied to be laboratory-based (prospective testing).
- Analytical Specificity: Two LDL Cholesterol concentrations (96.75 mg/dl and 193.5 mg/dl) were tested against various interferent levels. Each interferent was tested. The specific number of replicates or total determinations per interferent is not specified, but inferred to be multiple to allow for mean value calculation. Data provenance is unspecified, but implied to be laboratory-based (prospective testing).
- Method Comparison with Predicate Device: 139 serum patient samples. Data provenance is unspecified, but these are patient samples, making this a retrospective or prospectively collected patient sample study. The country of origin for these patients is not specified.
- Matrix Comparison: 70 matched patient sample pairs (serum and lithium heparin plasma). Data provenance is unspecified, but these are patient samples, making this a retrospective or prospectively collected patient sample study. The country of origin for these patients is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of in vitro diagnostic device (quantitative measurement of a biomarker), "ground truth" is typically established by reference methods or highly characterized calibrators/control materials, rather than expert human interpretation.
- Precision, Linearity, Detection Limit, Analytical Specificity: Ground truth is based on the known concentrations of analytes in control materials, spiked samples, or reference preparations.
- Method Comparison and Matrix Comparison: The ground truth for comparative studies is the measurement obtained from the "predicate device" or the paired sample (e.g., serum for matrix comparison). This is an analytical comparison rather than a clinical ground truth requiring expert consensus on a diagnosis.
- Therefore, the concept of "number of experts" and "qualifications of experts" used for establishing ground truth as it would apply to imaging or diagnostic interpretation is not applicable here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Given that this is an in vitro diagnostic device for quantitative measurement, adjudication methods typically used for subjective interpretations (like medical imaging diagnosis) are not applicable. The device provides a numerical output.
- Results are compared to established reference values or predicate device measurements directly. Any discrepancies would be investigated through re-testing or troubleshooting, not through a formal adjudication process between experts primarily for the test set results.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study applies to devices that assist human readers (e.g., radiologists interpreting images). The "Direct LDL Cholesterol (LDL)" device is an in vitro diagnostic assay that generates a quantitative result directly from a patient sample; it does not involve human "readers" in the context of interpretation that an MRMC study would assess.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this entire submission describes the standalone performance of the Direct LDL Cholesterol (LDL) assay system. It is an automated in vitro diagnostic test that provides a measurement result without human intervention for interpretation beyond operating the instrument and reviewing the numerical output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used is measurements from reference methods, predicate devices, or traceable calibrator/control values.
- For method comparison, the predicate device's measurements serve as the comparator.
- For precision, linearity, and detection limit, the "ground truth" refers to the known concentrations of the analyte in the prepared samples and controls.
- The device mentions traceability to an "internal master reference material" for calibrators, which is a form of analytical ground truth.
The sample size for the training set:
- The document does not provide details on a "training set" in the context of machine learning, because this device is a chemical reagent-based assay, not an AI/ML algorithm.
- The study describes the validation of the analytical performance of the reagent system and its associated instrument for quantitative measurement. The concept of training data, as used in AI, does not apply here.
How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML sense, this question is not applicable. The analytical performance of the assay is based on chemical reactions and spectrophotometric measurements, calibrated against materials with known LDL Cholesterol concentrations.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a caduceus, with three abstract human profiles facing right. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 20, 2017

RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG OA/RA MANAGER 55 DIAMOND ROAD CRUMLIN CRUMLIN, GB BT29 40Y ANTRIM UNITED KINGDOM

Re: K161691

Trade/Device Name: Direct LDL Cholesterol (LDL) Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: I, meets the limitations of exemption 21 CFR 862.9(c)(4) Product Code: MRR Dated: February 6, 2017 Received: February 9, 2017

Dear Dr. Pauline Armstrong:

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. Isting 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.

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

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as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

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 Industry and Consumer Education 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 vours.

Kellie B. Kelm -S

for Courtney 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

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Indications for Use

510(k) Number (if known) K161691

Device Name Direct LDL Cholesterol (LDL)

Indications for Use (Describe)

This in vitro diagnostic device is intended for prescription use only.

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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510(K) SUMMARY, DIRECT LDL CHOLESTEROL (LDL)

1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT

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

2. SUBMITTER NAME AND ADDRESS

Name: Dr Pauline Armstrong

Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.

Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com

Date of Summary Preparation: 16 March 2017

3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER

510k No: K161691

Device Proprietary Name: Direct LDL Cholesterol (LDL)

Common Name: Direct LDL Cholesterol (LDL)

Purpose for Submission: New Device

Product Code	Regulation Name	Classification	Regulation Section	Panel
MRR	Lipoprotein test system	Class I, meets the limitation of exemption 21 CFR §862.9(c)(4)	21 CFR §862.1475 Lipoprotein Test System	Clinical Chemistry (75)

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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS

Predicate Device Proprietary Name:

Randox Laboratories Ltd., Direct LDL Cholesterol Reagent

510 (k) Number: K982529

5. INTENDED USE

For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. This in vitro diagnostic device is intended for prescription use only.

6. DEVICE DESCRIPTION

The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312

R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL

REAGENT COMPOSITION

Contents	Initial Concentration of Solution
R1. Enzyme Reagent 1PIPES BufferPiperazine-1, 4-bis (2-ethanesulfonic acid)HDAOSN-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxylaniline, sodium saltCholesterol Esterase[E.C.3.1.1.13. Microorganism, 37°C]Cholesterol Oxidase[E.C.1.1.3.6. Streptomyces sp, 37°C]Catalase[E.C.1.11.1.6. Microbial]Ascorbate Oxidase[E.C.1.10.3.3. Acremonium sp.]Surfactant	50 mmol/l, pH 7.02.0 mmol/l≥600U/I≥500U/I≥600KU/I≥300U/I0.3% (w/v)
R2. Enzyme Reagent 2PIPES BufferPiperazine-1, 4-bis (2-ethanesulfonic acid)4-Amino antipyrinePeroxidase[E.C.1.11.1.7, Horse Radish, 25°C]SurfactantSodium Azide	50 mmol/l, pH 7.04 mmol/l≥4KU/I1.00% (w/v)0.05% (w/v)

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Materials required but not provided.

Direct HDL-C/LDL-C Calibrator, CH2673 (K122126). Randox Lipid Controls (K022591):-LE 2661 or LE 2668 Level 1 Level 2 LE 2662 or LE 2669 Level 3 LE 2663 or LE 2670 RX series Saline (Cat. No. SA8396)

7. PREDICATE DEVICE COMPARISON TABLE

Table 1 - Comparison of LDL Cholesterol test system for the RX Daytona Plus to

Predicate device

Characteristics	LDL Cholesterol Assay forRX daytona plus(New Device)	Randox LDL cholesterol (K982529)(Predicate Device)
		Similarities
Intended Use	For the quantitative in vitro determinationof LDL-cholesterol concentration inhuman plasma and serum.	Same
Assay Protocol	Clearance Method	Same
Storage(Unopened)	Reagents are stable up to the expiry datewhen stored unopened at +2 to +8°C	Same
Sample Type	Serum, Heparinized Plasma are therecommended samples.	Same
		Differences
Measuring Range	21 - 740 mg/dl	7.3 to 859 mg/dl

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8. TEST PRINCIPLE (1, 2)

The assay consists of 2 distinct reaction steps:

1. Elimination of chylomicron, VLDL-Cholesterol and HDL-Cholesterol by cholesterol esterase, cholesterol oxidase and subsequently catalase.
  Cholesterol esterase Cholesterol ester -→Cholesterol + fatty acid Cholesterol oxidase Cholesterol + O2 → Cholestenone + H2O2 Catalase 2H2O + O2 2H2O2
1. Specific measurement of LDL-Cholesterol after release of LDL-Cholesterol by detergents in Reagent 2.

$$\text{Cholesterol ester} \xrightarrow{\text{Cholesterol esterase}} \text{Cholesterol + fatty acid}$$

$$\text{Cholesterol + O}{2} \xrightarrow{\text{Cholesterol oxidase}} \text{Cholestenone + H}{2}\text{O}_{2}$$

$$2\text{H}{2}\text{O}{2} + \text{4-AA + HDAOS} \xrightarrow{\text{Peroxidase}} \text{Quinone pigment+4H}_{2}\text{O}$$

The intensity of the quinoneimine dye produced is directly proportional to the cholesterol concentration when measured at 600 nm.

In the second reaction catalase is inhibited by sodium azide in Enzyme Reagent 2.

Key: 4 - AA - 4 - Aminoantipyrine HDAOS = N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxylaniline, sodium salt

1. Weiland H. and Seidel D., J Lip Res, 24: 904-909, 1983.

Friedewald W.F., et al, Clin Chem, 18: 499-502, 1972.

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9. PERFORMANCE CHARACTERISTICS

Analytical performance:

a. Precision/Reproducibility:

Precision was evaluated consistent with C.L.S.I documents EP5-A2. Precision studies were performed by two operators on two RX Daytona plus svstems using control material and unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges <100mg/dl optimal LDL cholesterol. 130 - 159 mg/dL borderline high LDL Cholesterol, 160 – 189 mg/dL high LDL Cholesterol, >190 mg/dL very high LDL Cholesterol. Testing was conducted for two reagent lots of Cholesterol levels, one lot on each RX Daytona plus system, twice per day for 20 non-consecutive days. Two replicates per run were performed for each sample. The assay was calibrated on the first day of the study and no assay recalibrations were required throughout the duration of the study. The results of Lot 2, which is representative of both lots of reagent, is summarized in the following table.

Lot 2			Mean		Within Run		Among Run		AmongDay		Total
Method	Product	N	(mg/dl)	SD	CV	SD	CV	SD	CV	SD	CV
LDL	QC 1	80	92.0	2.7	3.0	4.6	5.0	0.8	0.9	5.4	5.9
LDL	QC 2	80	135.9	3.8	2.8	4.1	3.0	2.6	1.9	6.2	4.6
LDL	QC 3	80	186.7	5.5	2.9	5.9	3.2	1.4	0.7	8.2	4.4
LDL	Serum pool 1	80	65.0	1.7	2.6	3.2	5.0	1.2	1.8	3.8	5.9
LDL	Serum pool 2	80	154.0	4.4	2.9	6.0	3.9	2.1	1.4	7.8	5.0
LDL	Serum pool 3	80	200.1	5.8	2.9	8.2	4.1	0.0	0.0	10.0	5.0
LDL	Serum pool 4	80	343.7	10.3	3.0	14.2	4.1	4.3	1.2	18.0	5.3

Table 2 Precision Summary

b. Linearity/assay reportable range:

Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration (or where deviation from linearity is less than 10%).

The linearity samples were prepared at 11 levels. The sponsor set a range from approximately 21 mg/dl analyte concentration up to a high concentration of approximately 850 mg/dl using low and high serum pools. The low and high pools were mixed to make nine intermediate levels. Each level was run in replicates of five on two lots of LDL Cholesterol reagent on one RX Daytona plus

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system. The observed values were compared to the expected values; the linear regression correlation between the expected values and the observed values are summarized in the following table:

Table 3 Linearity Summary including Regression equation and correlation co-efficient.

Analyte Tested	LDL Cholesterol(mg/dl)
LinearRegression	$Y = 0.99x +6.34$
r	0.997

The reportable range of the assay is 21-740 mg/dl.

Samples with concentrations greater than the linearity limit established are returned > 740 mg/dL and are re-run automatically by the RX daytona plus using the established high re-run conditions.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Refer to K122126 Direct HDL/LDL Calibrator and K022591 Lipid Controls.

The Direct HDL-C/LDL-C Calibrator is traceable to an internal master reference material. Calibrators are value assigned using one instrument and multiple repetitions. The mean, standard deviation, and % CV are calculated and evaluated against acceptance criteria.

The reagent system has not been tested or certified by the Cholesterol Reference Method Laboratory Network (CRMLN). The labeling contains language that the device has not been certified by the CRMLN.

d. Detection limit:

Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2 'Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline'. A Limit of Blank (L.o.B), a Limit of Detection (L.o.D) and a Limit of Quantification (L.o.Q) were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.

The Limit of Detection (LoD) for LDL Cholesterol on the RX Daytona Plus is 3.19 mg/dl based on 240 determinations, with 4 low level samples.

The Limit of Blank (LoB) is 1.94 mg/dl.

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The Limit of Quantitation (LoQ) is 16.1 mg/dl as determined by the lowest concentration detected with ≤20% imprecision.

e. Analytical Specificity:

Interference studies have been carried out in accordance with C.L.S.I. guideline EP7-A2 'Interference testing in clinical chemistry; Approved Guideline Second Edition'. The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. The spiked sample results were compared to control samples prepared without the potential interferents.

Acceptance Criteria: % of Control ± 10%

The following analytes were tested up to the levels indicated at LDL Cholesterol concentrations of 96.75 mg/dl and 193.5 mg/dl and found not to interfere:

Hemoglobin	No significant interference up to 1000mg/dl.
Total Bilirubin	No significant interference up to 60mg/dl.
Conjugate Bilirubin	No significant interference up to 60mg/dl.
Triglycerides	No significant interference up to 500mg/dl.
Intralipid®	No significant interference up to 500mg/dl.
Ascorbic Acid	No significant interference up to 6mg/dl.

f. Method comparison with predicate device:

Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'.

The candidate device on the RX Daytona Plus analyzer, was tested against the predicate device on the RX Imola analyzer.

139 serum patient samples spanning the range 22.45 to 735.68 mg/dl were tested by two operators on two lots of LDL cholesterol reagent, across 3 working days with each sample tested in singlicate.

The candidate device was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.01x - 1.45 Correlation coefficient of r = 0.998

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q. Matrix comparison:

Matrix method comparisons for the LDL cholesterol assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of LDL cholesterol reagents. Both serum and lithium heparin plasma were tested to determine whether method accuracy with plasma specimens are equivalent to serum results and that lithium heparin plasma does not interfere with either the method or the system.

LDL Cholesterol matrix comparison on the RX Daytona plus (Lithium Heparin)

Patient samples were drawn in matched pairs – one sample serum (x) and the second sample lithium heparin plasma (y). 70 matched patient sample pairs were analyzed spanning the range 25.45 to 665.64 mg/dl and the following linear regression equation was obtained:

Y = 1.01x -2.81 Correlation coefficient of r = 0.998

Expected values/Reference range:

Referenced from literature

Table 4 Reference Ranges

Analyte	Serum
LDL Cholesterol (3)	< 100 mg/dL optimal130 – 159 mg/dL borderline high160 – 189 mg/dL high>190 mg/dL very high

Third Report of the National Cholesterol Education Programme (NCEP) Expert Panel on Detection, Evaluation and treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215 September 2002

10. CONCLUSION

Testing results indicate that the proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.