# K070017: PTS Panels Metabolic Chemistry Panel Test Strips

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jan 31, 2007 after 28 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 K980731 (1998). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013068: Bioscanner 2000, Polymer Technology Systems, Inc. (2001) Summary page 2.
- K060617: PTS Panels HDL Cholesterol Test Strips, Polymer Technology Systems, Inc. (2006) Summary page 2.
- K991894: Bioscanner Triglycerides Test Strips, Polymer Technology Systems, Inc. (2000) Summary page 2.
- K000586: Bioscanner Triglycerides Test Strips, Polymer Technology Systems, Inc. (2000) Summary page 2.

## Most influential descendants
- K142302: BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System (2014), 0 descendants of its own

## Indications for use
PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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. Triglycerides 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.

Source page: https://510kreport.com/device/K070017
Methodology: https://510kreport.com/methodology