Who else makes this device?

Name: Accu-Chek Guide
Brand: Accu-Chek Guide

Accu-Chek Guide · System, Test, Blood Glucose, over the Counter → Clinical Chemistry

20manufacturers in China registered for this device type

10catalogue numbers in this listing

1510(k) clearance

5recalls on this code

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NBW
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Dongguan Honfield Precision Parts Co., Ltd.	Zhangmutou, Dongguan	Guangdong	Contract manufacturer	8
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6
Flextronics Industrial (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	5
Yasee Biomedical Inc	Qingdao	Shandong	Contract manufacturer	5
Altek Medical (kunshan) limited	Kunshan Free Trade Zone	Jiangsu	Contract manufacturer	2
Dongguan Kaifa Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	2
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Andon Health Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	22
Vivachek Biotech (Hangzhou) Co., Ltd.	Hangzhou, Zhuji	Zhejiang	Contract manufacturer	21

Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter

Record

Regulatory record for Accu-Chek Guide
Listed by	Roche Diagnostics Operations, United States
FDA product code	NBW
Device type	System, Test, Blood Glucose, Over The Counter
Device class	Class 2
Regulation	21 CFR 862.1345
510(k)	K160944
Record published	2017-02-02
Record revised	2023-07-06 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, serial number
Packaging	Pack of 20, pack of 10, pack of 36
Distribution end date	2018-11-08

Catalogue Numbers

Catalogue numbers for Accu-Chek Guide
Catalogue number	Size	Status
07400942001		In distribution
10439050001		In distribution
08453071001		In distribution
10436271001		In distribution
08387052001		In distribution
08453063001		In distribution
07398794001		In distribution
10439165001		In distribution
07400870001		Withdrawn
07400926001		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
True Metrix	Trividia Health, Inc.	40
Fora	Fora Care Inc.	31
True Metrix AIR	Trividia Health, Inc.	21
GE	Bionime Corporation	21
TRUEtrack	Trividia Health, Inc.	17
Medline	Medline Industries, Inc.	15
AgaMatrix	Agamatrix	15
Tenovi	Tenovi Co	13
Auvon	Shenzhen Yuwen E-Commerce Co., Ltd.	11
Curaplex	Bound Tree Medical, LLC	10
OneTouch Verio	Lifescan Europe Gmbh	10
Rightest	Bionime Corporation	9

Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K131029	2013-08-09

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Accu-Chek Guide
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Roche Diabetes Care, Inc.	510(k) number	2024-05-13	Class II	Reprocessing Controls	The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times low	48 units
Roche Diabetes Care, Inc.	510(k) number	2019-09-30	Class II	Device Design	Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.	318,678	2020-07-29

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2014-04-14	Class II	Device Design	Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.	590,136 boxes	2014-09-18
2013-10-25	Class II	Software design	There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation	6,595 units	2015-01-14
2013-03-06	Class II	Device Design	Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or	Both devices 4467	2018-01-10
2012-03-12	Not classified	Employee error	Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a manufacturing process for product to be distributed outside the US were distributed in the US through eBay by an unauthorized third party. The	82 meter distributed on Ebay	2012-11-06
2011-05-18	Not classified	Component design/selection	Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197.	27,019 units	2011-10-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Accu-Chek Guide