Who else makes this device?

Name: K-Assay® Multi-Analyte Calibrator
Brand: K-Assay® Multi-Analyte Calibrator

Clinical Chemistry › Test SystemsCalibrator, Multi-Analyte Mixture

K-Assay® Multi-Analyte Calibrator

For the calibration of the K-ASSAY® Alpha-1 AG, Alpha-1 AT, Complement C3, Comlement C4, Haptoglobin, IgA, IgG, IgM, and Transferrin assays.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code JIX
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for K-Assay® Multi-Analyte Calibrator
Listed by	Kamiya Biomedical Company LLC, United States
FDA product code	JIX
Device type	Calibrator, Multi-Analyte Mixture
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Repacker / relabeller, Manufacturer
510(k)	K993853
Record published	2016-09-16
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for K-Assay® Multi-Analyte Calibrator
Catalogue number	Size	Status
KAI-016C		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stat Profile	Nova Biomedical Corporation	54
BioPlex 2200	Bio-Rad Laboratories Inc.	32
Plasma Calibrator Set	Chromsystems Instruments & Chemicals Gmbh	22
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	20
Nova	Nova Biomedical Corporation	15
Plasma Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	15
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	15
Architect	Abbott Laboratories	11
Alinity	Abbott Medical	10
Synchron	Beckman Coulter, Inc.	9
Architect	Abbott Medical	9
Urine Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	8

Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K993853	1999-12-27
K993606	1999-11-26
K991166	1999-06-10

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of K-Assay® Multi-Analyte Calibrator
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Kamiya Biomedical Company LLC	510(k) number	2017-07-19	Class II	Under Investigation by firm	The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.	1398 units	2018-11-20

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.