# K182781: PTS Professional Chemistry Kit

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
- Decided: Dec 21, 2018 after 81 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K870012 (1987). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140068: Cardiochek Plus Test System, Cardiochek Home Test System, Polymer Technology Systems, Inc. (2015) Summary page 4.
- K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec, Bayer Healthcare, LLC (2009) Summary page 4.

## Recalls of this device
- Jan 16, 2019 · Class II · Z-1373-2019: Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed

## Indications for use
The PTS Professional Chemistry Kit is a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in capillary (fingerstick) or venous whole blood. • Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. • HDL (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. • Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. • The HbA1C test provides quantitative measurement of the percent of glycated hemoglobin levels. The test is for professional use to monitor glycemic control in people with diabetes.

Source page: https://510kreport.com/device/K182781
Methodology: https://510kreport.com/methodology