510(k) · Cleared

Cleared

i-Stat Alinity System with i-Stat Glucose test

K163271510(k) TraditionalCleared Apr 10, 2017140-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

Abbott Point of Care, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Apr 10, 2017 as substantially equivalent to K103195 (Abbott Point of Care, Inc., 2011) after a 140-day review. Its family tree reaches back 2 generations to 2000.

Decided: Apr 10, 2017
Review: 140 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K001387 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
1 generation backK103195 I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc. · 2011
This deviceK163271 i-Stat Alinity System with i-Stat Glucose testAbbott Point of Care, Inc. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K001387	I-Stat Portable Clinical Analyzer, Model 300	I-Stat Corp.	2000	13
−1	K103195	I-Stat 1 Wireless Analyzer	Abbott Point of Care, Inc.	2011	—
0 (this device)	K163271	i-Stat Alinity System with i-Stat Glucose test	Abbott Point of Care, Inc.	2017	—

FIG. 1 — Lineage of K163271, 2000–2017Source: 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? (1)

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
*	K103195	I-Stat 1 Wireless Analyzer Summary page 4 …st System 862.1345 II Clinical Chemistry 3. Predicate Device Proprietary Name i-STAT 1 Wireless Analyzer 510(k) Number K103195 Product Device Classification Regulation Class Panel code name…	Abbott Point of Care, Inc.	2011	—

Also cleared against K103195: 2 other devices →

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 17 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K103195.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

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 i-STAT Alinity System with i-STAT Glucose test is intended for use in point of care or clinical laboratory settings.

The i-STAT Alinity System with Glucose test is intended for the quantitative measurement of glucose in arterial and venous whole blood.

Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The i-STAT Glucose test with the i-STAT Alinity System has not been evaluated in neonates.

For in vitro diagnostic use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163271 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163271: i-Stat Alinity System with i-Stat Glucose test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163271

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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