PreciControl ClinChem Multi 2
PreciControl ClinChem Multi 2 is a human-serum quality-control material for quantitative clinical chemistry tests. It is supplied in a freeze-dried form, with added constituents that adjust…
PreciControl ClinChem Multi 2 is a human-serum quality-control material for quantitative clinical chemistry tests. It is supplied in a freeze-dried form, with added constituents that adjust the levels of the components measured by laboratory methods.
Component concentrations and assigned values are specific to each lot. Laboratories use the values supplied for the applicable methods to monitor the accuracy and precision of their measurements. Multi 2 belongs to the PreciControl ClinChem Multi 1 and 2 control range.
Control Composition
The control range contains components for enzyme, electrolyte, lipid and protein measurements. Examples include glucose, creatinine, sodium, potassium, alanine aminotransferase and immunoglobulin G. The accompanying value sheets identify the quantitative methods for which the control is intended.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K102016 |
| Record published | 2021-01-18 |
| Record revised | 2026-02-23 (version 2) |
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 number | Size | Status |
|---|---|---|
| 5947774160 | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K111506 | 2011-07-08 |
| K102016 | 2010-09-01 |
| K102157 | 2010-08-27 |
| K092320 | 2009-11-03 |
| K090541 | 2009-07-02 |
| K070200 | 2007-03-19 |
| K062379 | 2007-01-31 |
| K060429 | 2006-03-15 |
| K051543 | 2005-10-17 |
| K051687 | 2005-07-25 |
| K051185 | 2005-07-06 |
| K051517 | 2005-07-05 |
| K050387 | 2005-04-25 |
| K042389 | 2004-09-14 |
| K041812 | 2004-07-27 |
| K041227 | 2004-05-27 |
| K040280 | 2004-03-11 |
| K033937 | 2004-01-07 |
| K032089 | 2003-07-30 |
| K000270 | 2000-03-07 |
| K993360 | 1999-11-24 |
| K992900 | 1999-11-24 |
Recalls
1 of these is 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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-10 | Class II | Process control | e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays | 1603 | 2017-08-04 |
| 2007-12-04 | Not classified | Software design | Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported. | 1 | 2008-08-04 |
| 2007-11-14 | Not classified | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. | 811 | 2009-09-22 |
| 2007-11-14 | Not classified | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. | 1,296 | 2009-09-22 |
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.