# K090405: Lipidpro System

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Dec 1, 2009 after 285 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K870252 (1987). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023558: PTS Panels Lipid Panel Test Strips, Polymer Technology Systems, Inc. (2002) Summary page 1.
- K072369: Evolution Blood Glucose Monitoring System, Hmd Biomedical, LLC (2008) Summary page 1.
- K022401: PTS Panels Multi-Chemistry Controls, Polymer Technology Systems, Inc. (2002) Summary page 4.

## Most influential descendants
- K130295: Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile and Glucose Measuring System. (2013), 0 descendants of its own

## Indications for use
LipidProtm system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidPro Tm system which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are < 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported. Glucose measurement is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly. LipidProTm Total Cholesterol control solution, HDL-cholesterol control solution, Triglyceride control solution, and Glucose control solution are used to test the precision of the LipidPro TM system and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only.) LipidPro TM control solutions are intended for in home and health care professionals use.

Source page: https://510kreport.com/device/K090405
Methodology: https://510kreport.com/methodology