(68 days)
Not Found
Not Found
No
The summary describes a chemical assay for measuring HDL-C and does not mention any AI or ML components.
No
This device is for in-vitro diagnostic use (quantitative determination of HDL-C in serum and plasma) and does not treat or alleviate a disease or condition.
Yes
The device is intended for the "quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma," which is a measurement used for diagnostic purposes.
No
The device description clearly outlines a chemical test principle involving enzymes and reagents, indicating a hardware component (the test kit itself) is necessary for the intended use.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma." This clearly indicates that the device is used to test biological samples (serum and plasma) outside of the body to obtain diagnostic information (HDL-C levels).
- Device Description: The description details a chemical test principle using enzymes and cyclodextrin to measure a substance in a biological sample. This is characteristic of an in vitro diagnostic test.
The definition of an IVD is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Boehringer Mannheim Direct HDL fits this definition perfectly.
N/A
Intended Use / Indications for Use
Boehringer Mannheim Direct HDL is intended for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Product codes
Not Found
Device Description
The Direct HDL test principle use PEG-modified enzymes and sulfated cyclodextrin. When cholesterol esterase and cholesterol oxidase enzymes are modified by PEG, they show selective catalytic activities toward lipoprotein fractions, with the rectivity increasing in the order LDL
§ 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.
0
| OCT | 23 | 1996 |
|---|---|---|
| ----- | ---- | ------ |
0(k) Summary
510(k) Summary K963213
۾ ..
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2327 |
| | Contact Person: John D. Stevens, RAC |
| | Date Prepared: August 14, 1996 |
| 2) Device name | Proprietary name: Boehringer Mannheim Direct HDL-Cholesterol |
| | Common name: HDL test |
| | Classification name: LDL and VLDL precipitation, cholesterol via esterase-
oxidase, HDL |
| 3) Predicate
device | We claim substantial equivalence to the Boehringer Mannheim HDL
Cholesterol |
| 4) Device
Description | The Direct HDL test principle use PEG-modified enzymes and sulfated
cyclodextrin. When cholesterol esterase and cholesterol oxidase enzymes are
modified by PEG, they show selective catalytic activities toward lipoprotein
fractions, with the rectivity increasing in the order LDL 1000 mg/dl
bilirubin > 65 mg/dl
lipemia > 600 mg/dl | hemoglobin > 79 mg/dl
bilirubin > 4 mg/dl
lipemia - not tested |