510(k) · Cleared

Cleared

Q.Steps Biometer G/C Dual Monitoring System

K050182510(k) TraditionalCleared Aug 9, 2005194-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomedix, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Aug 9, 2005 as substantially equivalent to K033627 (Biomedix, Inc., 2004) and 2 other predicates after a 194-day review. Its family tree reaches back 2 generations to 1999.

Decided: Aug 9, 2005
Review: 194 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K990688 (1999). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990688 MTM Bioscanner C Test StripsPolymer Technology Systems, Inc. · 1999 · Recalled
1 generation backK023558 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
This deviceK050182 Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990688	MTM Bioscanner C Test Strips	Polymer Technology Systems, Inc.	1999	1
−1	K023558	PTS Panels Lipid Panel Test Strips	Polymer Technology Systems, Inc.	2002	2
0 (this device)	K050182	Q.Steps Biometer G/C Dual Monitoring System	Biomedix, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0
2003	1	0
2004	1	0

FIG. 1 — Lineage of K050182, 1999–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CGA device

#1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K033627	Q.Steps Biometer G Blood Glucose Monitoring System Summary page 2 …arance 9. Predicate Devices The predicate devices for determination of Substantial Equivalence are: 1. Q.STEPS T Biometer G Blood Glucose Monitoring System (K033627) 2. Polymer Technology Systems, Inc., PTS PANELS Lipid Panel Test Strips (K023558)) 3. One Touch Basic/Profile/One Touc…	Biomedix, Inc.	2004	—
*	K023558	PTS Panels Lipid Panel Test Strips Summary page 2 …ial Equivalence are: 1. Q.STEPS T Biometer G Blood Glucose Monitoring System (K033627) 2. Polymer Technology Systems, Inc., PTS PANELS Lipid Panel Test Strips (K023558)) 3. One Touch Basic/Profile/One Touch II Test Strips, LifeScan, Inc.(K031472) Pa…	Polymer Technology Systems, Inc.	2002	2
*	K031472	One Touch Basic/Profile/One Touch II Test Strips Summary page 2 …K033627) 2. Polymer Technology Systems, Inc., PTS PANELS Lipid Panel Test Strips (K023558)) 3. One Touch Basic/Profile/One Touch II Test Strips, LifeScan, Inc.(K031472) Page 2 of 2 DEPARTMENT OF HEALTI1 & HIUMAN SERVICES…	Lifescan, Inc.	2003	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
2 of the 6 ancestors have a recall of any class.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007high 441 (2013) · low 56 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CGA

3in 2023

2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	122	2	29
2008	6	56	2	37
2009	10	155	4	75
2010	8	122	6	172
2011	9	217	3	423
2012	10	123	0	233
2013	3	441	3	172
2014	5	265	2	122
2015	4	150	6 (2)	155
2016	4	157	2	36
2017	2	—	0	92
2018	2	—	0	69
2019	2	—	1	116
2020	2	—	0	68
2021	1	—	0	48
2022	1	—	0	272
2023	4	249	3	1,141
2024	2	—	0	266
2025	0	—	0	59
2026	1	—	0	—

What is it indicated for?

The Q.STEPS Biometer G/C Dual Monitoring System is intended for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C by healthcare professionals and home users. Q.STEPS Biometer G/C System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050182 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050182: Q.Steps Biometer G/C Dual Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050182

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026