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K Number
K162593
Device Name
HDL-Cholesterol Gen.4
Manufacturer
Roche Diagnostics Operations (RDO)
Date Cleared
2016-10-19

(33 days)

Product Code
LBS
Regulation Number
862.1475
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems. 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.
Device Description
The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.
More Information

K021316

Not Found

No
The device description and performance studies focus on enzymatic and colorimetric methods for quantitative determination, with no mention of AI or ML techniques.

No
The device is an in vitro diagnostic test for measuring HDL-cholesterol concentration, which is used in the diagnosis and treatment of lipid disorders, not for direct therapeutic intervention.

Yes

The "Intended Use / Indications for Use" section explicitly states "In vitro diagnostic test" and that the "measurements are used in the diagnosis and treatment of lipid disorders".

No

The device is an in vitro diagnostic test that involves a homogeneous enzymatic colorimetric test performed on a Roche/Hitachi cobas c system, indicating it is a reagent and requires specific hardware for operation.

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

Here's why:

  • Intended Use/Indications for Use: The document explicitly states "In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma". This directly aligns with the definition of an IVD, which is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state or in order to ascertain the state of health in human beings.
  • Device Description: The description details a "homogeneous enzymatic colorimetric test" performed on "human serum and plasma". This describes a laboratory test performed on biological samples outside of the body, which is characteristic of an IVD.
  • Purpose of Measurement: The intended use states that the measurements are "used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This clearly indicates the device is used to provide information for medical diagnosis and treatment, a key function of an IVD.

N/A

Intended Use / Indications for Use

In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

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.

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

LBS

Device Description

The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.

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

Not Found

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)

Precision according to CLSI EP5-A3

  • Repeatability and Intermediate Precision
  • Study design: 4 individual replicates tested in one run per day for 21 days. Two replicates were tested at the beginning of the run, followed by 10 patient samples and then two replicates were tested at the end of the run.
  • Sample size: Five human serum pools and two control samples.
  • Results:
    • Repeatability Summary (Mean (mg/dL), SD (mg/dL), CV (%)):
      • PreciControl ClinChem Multi 1: 28.0, 0.20, 0.7
      • PreciControl ClinChem Multi 2: 68.1, 0.44, 0.6
      • Human Serum 1: 9.48, 0.17, 1.8
      • Human Serum 2: 40.5, 0.26, 0.7
      • Human Serum 3: 59.4, 0.32, 0.5
      • Human Serum 4: 79.4, 0.51, 0.6
      • Human Serum 5: 141, 0.83, 0.6
    • Intermediate Precision Summary (Mean (mg/dL), SD (mg/dL), CV (%)):
      • PreciControl ClinChem Multi 1: 28.4, 0.30, 1.1
      • PreciControl ClinChem Multi 2: 66.4, 0.9, 1.4
      • Human Serum 1: 9.48, 0.20, 2.2
      • Human Serum 2: 40.7, 0.33, 0.8
      • Human Serum 3: 59.4, 0.40, 0.7
      • Human Serum 4: 79.4, 0.65, 0.8
      • Human Serum 5: 141, 1.07, 0.8

Detection Limit: LoB, LoD and LoQ according to CLSI EP17-A2

  • Limit of Blank (LoB)
    • Study design: One analyte free sample measured on three lots of reagent in 10-fold determinations in 6 runs, distributed over 3 days, on one analyzer.
    • Sample size: 60 measurements per reagent lot.
    • Results: LoB Observed: 0.00 mg/dL, LoB Claim: 3.09 mg/dL
  • Limit of Detection (LoD)
    • Study design: Five samples with low-analyte concentration (approximately up to 4 times the LoB) measured with three lots of reagent in two-fold determination in 6 runs, distributed over 3 days, on one analyzer.
    • Sample size: 60 measurements per lot of reagent.
    • Results: LoD Observed: 0.50 mg/dL, LoD Claim: 3.09 mg/dL
  • Limit of Quantitation (LoQ)
    • Study design: A low level sample set was prepared by diluting 5 human serum samples with an analyte free diluent (0.9% NaCl). The low level sample set was tested in 5 replicates per sample on 5 days, one run per day on one analyzer.
    • Results: LoQ Observed: 2.89 mg/dL, LoQ Claim: 3.09 mg/dL

Linearity according to CLSI EP6-A

  • Study design: Dilution series were prepared using human sample pools (1 serum pool and 1 plasma pool) with HDL-C concentrations above the upper end of the measuring range. Dilutions were made using 0.9% NaCl. The dilution series contain 11 concentrations for serum and 15 concentrations for plasma. Sample dilution levels were measured in triplicate.
  • Results: The nonlinearity of the assay did not deviate by more than 10% during testing.
    • Linearity Results (Slope, Intercept, Correlation Coefficient (r2), Repeatability, Claimed Measuring Range):
      • Serum: 1.020, -0.399, 0.9992, 1.5%, 3.09 to 150 mg/dL
      • Plasma: 1.022, -0.173, 0.9929, 0.8%, 3.09 to 150 mg/dL

Endogenous Interferences - H, L and I Indices

  • Study design: The effect on quantitation of analyte in the presence of endogenous interfering substances was determined at two HDL-Cholesterol concentrations (approximately 33 and 65 mg/dL) and a dilution set of the added interfering substances. Interfering substances included Hemolysis (up to H index 1200), Lipemia (up to L index 2000), Icterus/Conjugated and Unconjugated Bilirubin (up to I index 60). Two human serum pools were spiked, and dilution series were prepared. Three aliquots per level were tested in 1 run on 1 instrument and 1 lot. Interference was defined as bias greater than 10%.
  • Results:
    • Hemolysis: No Interference up to 1200 H index
    • Lipemia: No Interference up to 2000 L index
    • Unconjugated Bilirubin: No Interference up to 60 I index
    • Conjugated Bilirubin: No Interference up to 60 I index

Endogenous Interferences - Triglycerides

  • Study design: The effect on quantitation of analyte in the presence of endogenous interfering substances was determined at two HDL-Cholesterol concentrations (approximately 33 and 65 mg/dL) and a dilution set of the added interfering substance. High concentrated stock solution of triglycerides was used. Two human serum pools were spiked, and dilution series were prepared. Three aliquots per level were tested in 1 run on 1 instrument and 1 lot. Interference was defined as bias greater than 10%.
  • Results: No Interference up to 1200 mg/dL Triglycerides

Exogenous Interferences - Drugs

  • Study design: Two human serum sample pools spiked with approximately 30 and 60 mg/dL HDL-Cholesterol concentrations were used. One aliquot of each concentration served as reference (not spiked). The other aliquots were spiked with various drugs at concentrations according to EP7-A2 or higher. The HDL-Cholesterol concentration of the spiked aliquots were tested with 3 replicates in one run, 1 reagent lot and one instrument.
  • Results: Not explicitly stated as pass/fail for each drug, but implies satisfactory performance based on no further commentary.

Method Comparison to Predicate

  • Study type: Method Comparison
  • Sample size: 111 routine laboratory serum samples. Four samples were spiked with high human serum HDL-Cholesterol. One sample was diluted with 0.9% NaCl.
  • Results: Data was evaluated using Passing Bablok Regression analysis.
    • Regression analysis results: y = 0.956x - 0.949, r = 0.995
    • Bias at medical decision points:
      • -6.7 % at 40.2 mg/dL
      • -6.0 % at 59.9 mg/dL

Matrix Comparison - Anticoagulants

  • Study design: Each pair of serum and plasma of a single donor were spiked with HDL-Cholesterol. The 38 paired sample tubes are tested in singlicate. Serum data was used as the reference. Only samples within the measuring range were used.
  • Results:
    • Linear Regression results:
      • Serum vs. Serum Gel Separation: y = 0.99x - 0.33, r = 0.999 (Range Tested: 3.48 to 145 mg/dL)
      • Serum vs. Li-heparin: y = 0.99x - 0.32, r = 1.000 (Range Tested: 3.48 to 147 mg/dL)
      • Serum vs. K2-EDTA: y = 0.98x - 0.70, r = 0.999 (Range Tested: 3.87 to 144 mg/dL)
      • Serum vs. K3-EDTA: y = 0.95x - 0.08, r = 0.999 (Range Tested: 3.87 to 145 mg/dL)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found (Performance metrics provided are precision, detection limits, linearity, and interference data).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Ultra N-geneous HDL Cholesterol Reagent, K021316

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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

ROCHE DIAGNOSTICS OPERATIONS (RDO) BARBARA MCWHORTER REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD SUITE 114 INDIANAPOLIS IN 46250

October 19, 2016

Re: K162593

Trade/Device Name: HDL-Cholesterol Gen.4 Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: I, meets the limitation of exemption 21 CFR §862.9(c)(4) Product Code: LBS Dated: September 14, 2016 Received: September 16, 2016

Dear Ms. McWhorter:

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.

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 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.

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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/ResourcesforYou/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 yours,

Katherine Serrano -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) K162593

Device Name HDL-Cholesterol Gen.4

Indications for Use (Describe)

In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

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.

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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HDL-Cholesterol Gen.4 510(k) Summary

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

In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).

The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the HDL-Cholesterol Gen.4 reagent.

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Submitter NameRoche Diagnostics
Address9115 Hague Road
P.O. Box 50416
Indianapolis, IN 46250-0457
ContactBarbara McWhorter
Phone: (317) 521-2336
FAX: (317) 521-2324
Email: barbara.mcwhorter@roche.com
Date PreparedSeptember 13, 2016
Proprietary NameHDL-Cholesterol Gen.4
Common NameHDL-Cholesterol
Classification NameLipoprotein test system
Product Codes,
Regulation NumbersLBS, 21 CFR § 862.1475, Class I, meets the limitations to the exemptions 21
CFR§ 862.9(c)(4)
Predicate DevicesUltra N-geneous HDL Cholesterol Reagent, K021316
Establishment RegistrationFor the HDL-Cholesterol Gen.4, the establishment registration number
for Roche Diagnostics GmbH in Mannheim, Germany is 9610126. The
establishment registration number for Roche Diagnostics in the United
States is 1823260.

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1. DEVICE DESCRIPTION

The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.

2. INDICATIONS FOR USE

In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

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.

TECHNOLOGICAL CHARACTERISTICS 3.

Cholesterol esters are broken down quantitatively into free cholesterol and fatty acids by CHER. In the presence of oxygen, cholesterol is oxidized by cholesterol oxidase to Δ4-cholestenone and hydrogen peroxide. In the presence of peroxidase, the hydrogen peroxide generated reacts with 4 -amino-antipyrine and EMSE to form a dye. The color intensity of this dye is directly proportional to the cholesterol concentration and is measured photometrically.

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Figure 1: Test Principle

CHER ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------HDL-cholesterol esters + Hoo In the presence of oxygen, cholesterol is oxidized by cholesterol oxidase to Δ4-cholestenone and hydrogen peroxide. CHOD ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------HDL-cholesterol + O2 A4-cholestenone + H2O2 In the presence of peroxidase, the hydrogen peroxide generated reacts with 4-amino-antipyrine and EMSE®) to form a dye. The color intensity of this dye is directly proportional to the cholesterol concentration and is measured photometrically. Peroxidase 2 H₂O₂ + 4-amino-antipyrine + —————— colored pigment + 5 H2O EMSEp) + H+ + H2O

The following table compares the HDL-Cholesterol Gen.4 with its predicate device, Ultra Ngeneous HDL Cholesterol Reagent (K021316).

Table 1: Assay Comparison

| Feature | Predicate Device
Ultra N-geneous HDL Cholesterol Reagent,
(K021316) | Candidate Device
HDL-Cholesterol Gen.4 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the quantitative measurement of high-
density lipoprotein cholesterol
(HDL-C) concentration in human serum or
plasma. | In vitro diagnostic test for the quantitative
determination of the
HDL-cholesterol concentration in human
serum and plasma on
Roche/Hitachi cobas c systems. |
| Feature | Predicate Device
Ultra N-geneous HDL Cholesterol Reagent,
(K021316) | Candidate Device
HDL-Cholesterol Gen.4 |
| Test Principle | The method is in a two reagent format and
depends on the properties of a unique
detergent, as illustrated. This method is based
on accelerating the reaction of cholesterol
oxidase (CO) with non-HDL unesterified
cholesterol and dissolving HDL selectively
using a specific detergent. In the first reagent,
non-HDL unesterified cholesterol is subject to
an enzyme reaction and the peroxide
generated is consumed by a peroxidase
reaction with DSBmT yielding a colorless
product. The second reagent consists of a
detergent capable of solubilizing HDL
specifically, cholesterol esterase (CE) and
chromogenic coupler to develop color for the
quantitative determination of HDL-C. This may
be referred to as the Accelerator Selective
Detergent methodology. | Cholesterol esters are broken down
quantitatively into free cholesterol and fatty
acids by CHER. In the presence of oxygen,
cholesterol is oxidized by cholesterol oxidase
to Δ4-cholestenone and hydrogen peroxide.
In the presence of peroxidase, the hydrogen
peroxide generated reacts with 4-amino-
antipyrine and EMSE to form a dye. The color
intensity of this dye is directly proportional to
the cholesterol concentration and is measured
photometrically. |
| Reagent
Composition | R1:
Cholesterol oxidase, (Fr: E. Coli),Peroxidase,
(Fr: Horseradish), N,N-bis(4-sulphobutyl)-
mtoluidine-disodium(DSBmT), Accelerator,
Preservative, Ascorbic Oxidase,(Fr: Curcubita
sp.)
R2:
Buffer, Cholesterol esterase (Fr:Pseudomonas
sp.), 4-Aminoantipyrine (4-AAP), Detergent
,Preservative | R1:
TAPSO buffer: 62.1 mmol/L, pH 7.77;
polyanion: 1.25 g/L; EMSE: 1.08 mmol/L;
ascorbate oxidase (cucurbita): ≥ 50 µkat/L;
peroxidase (horseradish): ≥ 166.7 µkat/L ;
detergent; BSA: 2.0 g/L; preservative
R2:
Bis-Tris buffer: 20.1 mmol/L, pH 6.70;
cholesterol esterase (microorganism): ≥ 7.5
µkat/L; cholesterol oxidase (recombinant E.
coli): ≥ 7.17 µkat/L; cholesterol oxidase
(microorganism): ≥ 76.7 µkat/L; peroxidase
(horseradish): ≥ 333 µkat/L; 4-amino-
antipyrine: 1.48 mmol/L; BSA: 3.0 g/L;
detergents; preservative |
| Sample
Type/Matrix | Serum
Plasma: EDTA or lithium or sodium
heparin. | Serum.
Plasma: Li-heparin, K2- and K3-EDTA plasma |
| Calibrator | Sekisui Diagnostics Ultra N-geneous® HDL
Cholesterol Calibrator or the HDL Ultra
Cholesterol Calibrator | S1: H2O
S2: C.f.a.s. Lipids |
| Feature | Predicate Device
Ultra N-geneous HDL Cholesterol Reagent,
(K021316) | Candidate Device
HDL-Cholesterol Gen.4 |
| Controls | The National Cholesterol Education Program
(NCEP) Lipid Standardization Panel (LSP)
recommends two levels of controls, one in the
normal range (40-65 mg/dL) and one near the
concentrations for decision making (