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Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

Page Type
Product Code
Definition
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Physical State
The assay uses surfactants and enzymes that react with certain groups of lipoproteins.
Technical Method
Quantitative colorimetric assay
Target Area
Human serum or plasma.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1475
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1475 Lipoprotein test system

§ 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.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]

Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

Page Type
Product Code
Definition
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Physical State
The assay uses surfactants and enzymes that react with certain groups of lipoproteins.
Technical Method
Quantitative colorimetric assay
Target Area
Human serum or plasma.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1475
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1475 Lipoprotein test system

§ 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.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]