Who else makes this device?

Name: SPE Control (1 x 2 mL)
Brand: SPE Control (1 x 2 mL)

Clinical Chemistry › Test SystemsMulti-Analyte Controls, All Kinds (Assayed)

SPE Control (1 X 2 Ml)

Catalogue number 5136, listed by Helena Laboratories, Corp., United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

11510(k) clearances naming this product code

1recall

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 SPE Control (1 x 2 mL)
Listed by	Helena Laboratories, Corp., 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, Repacker / relabeller, Manufacturer, Exporter
510(k)	K821982
Record published	2017-03-17
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for SPE Control (1 x 2 mL)
Catalogue number	Size	Status
5136		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
K131479	2013-10-07
K924915	1992-12-18
K920927	1992-06-19
K920926	1992-05-07
K833639	1984-01-04
K821982	1982-08-16
K811695	1981-07-01
K802109	1980-10-10
K802108	1980-10-10
K792025	1979-10-30
K792024	1979-10-30

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 SPE Control (1 x 2 mL)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Helena Laboratories, Corp.	510(k) number	2016-10-14	Class II	Process control	Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.	65 kits	2023-10-12

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.