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abbott lyophilized assayed chemistry control 3 model 4e39-01
Bio-Rad
Summary: The Abbott Lyophilized Assayed Chemistry Control 3 by Bio-Rad is a quality control material used in clinical chemistry. It ensures accuracy in laboratory testing. Key evidence highlights its role in standardizing test results across laboratories.
FDA Clearance Information
Pathway
510K
Number
K990391 ↗
Decision Date
March 15, 1999
Product Code
JJY
Device Class
Class 1
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on March 15, 1999. It is manufactured by Bio-Rad and classified as a Class 1 device under product code JJY.
What It Is
The Abbott Lyophilized Assayed Chemistry Control 3 is a control material used in clinical laboratories to ensure the accuracy and reliability of chemistry assays. It is intended for use in quality control processes to verify the performance of laboratory tests.
Clinical Applications
This device is commonly used in clinical laboratories to standardize and validate the accuracy of various chemistry assays. It is particularly useful in ensuring consistent test results across different laboratories and testing methods.
Evidence Summary
The available literature includes five studies, ranging from 1995 to 2025, with various study designs such as RCTs and case-control studies. These studies focus on the commutability and standardization of control materials in laboratory settings.
Reported Outcomes
Published studies report that the Abbott Lyophilized Assayed Chemistry Control 3 effectively reduces inter-laboratory and inter-method variability in test results. It has been shown to improve the standardization of glycohemoglobin and enzyme measurements, enhancing the reliability of laboratory data.
Safety Profile
Reported complications include no significant adverse events associated with the use of this control material. The studies did not highlight any safety concerns, indicating its safe application in laboratory settings.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically evaluating this device. Further research is needed to explore its performance across a broader range of clinical settings and assay types.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Abbott Lyophilized Assayed Chemistry Control 3?
The device is indicated for use in quality control processes to ensure the accuracy and reliability of clinical chemistry assays.
What outcomes have been reported in clinical studies?
Studies have reported improved standardization and reduced variability in laboratory test results when using this control material.
What complications have been reported?
No significant complications or adverse events have been reported in the available studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.