Who else makes this device?

Name: Architect
Brand: Architect

Architect · Multi-Analyte Controls, All Kinds (Assayed) → Clinical Chemistry

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

2recalls on this code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JJY
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Architect
Listed by	Abbott Laboratories, United States
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-09
Record revised	2024-02-21 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Storage	Handling environment temperature up to 29 °C; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Architect
Catalogue number	Size	Status
6K26-30		In distribution
6K26-21		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Liquichek	Bio-Rad Laboratories Inc.	154
Validate	LGC Clinical Diagnostics, Inc.	120
InteliQ	Bio-Rad Laboratories Inc.	50
Lyphochek	Bio-Rad Laboratories Inc.	39
Stat Profile	Nova Biomedical Corporation	38
i-STAT	Abbott Point OF Care Inc.	24
Multichem AE	Techno-Path Manufacturing Ltd.	20
Serum Control	Chromsystems Instruments & Chemicals Gmbh	18
BioPlex 2200	Bio-Rad Laboratories Inc.	16
Nova	Nova Biomedical Corporation	14
Plasma Control	Chromsystems Instruments & Chemicals Gmbh	14
Multichem IA Speciality	Techno-Path Manufacturing Ltd.	12

Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K992710	1999-11-24

Recalls

2 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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
2019-04-09	Class III	Under Investigation by firm	Devices were delivered without the required dry ice.	1 unit	2019-12-20
2019-04-09	Class III	Under Investigation by firm	Devices were delivered without the required dry ice.	1 unit	2019-12-20

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.

Architect