# K090057: ON-Call Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Acon Laboratories Co.
- Decided: Apr 8, 2009 after 90 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: 1 generation back to K002134 (2000). 1 ancestor in all.
17 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002134: One Touch Ultra Blood Glucose Monitoring System, Selfcare, Inc. (2000) Summary page 1.

## Most influential descendants
- K113332: ON Call Chosen Lancing Device (2012), 16 descendants of its own
- K220475: Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) (2022), 7 descendants of its own
- K243306: Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (2024), 3 descendants of its own
- K153670: Genteel Lancing Device (2016), 3 descendants of its own
- K221970: Lancing device (2022), 2 descendants of its own

## Indications for use
The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs. The On-Call® Plus Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. The On-Call® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K090057
Methodology: https://510kreport.com/methodology