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abbott lyophilized assayed chemistry control models 1e86-02 1e87-02
Bio-Rad
Summary: The Abbott Lyophilized Assayed Chemistry Control, manufactured by Bio-Rad, is a quality control device for clinical chemistry assays. It is primarily used to ensure the accuracy and reliability of laboratory tests. Key evidence highlights its role in standardizing test results across laboratories.
FDA Clearance Information
Pathway
510K
Number
K990394 ↗
Decision Date
March 18, 1999
Product Code
JJY
Device Class
Class 1
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on March 18, 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 is a quality control device used in clinical laboratories to validate the accuracy of chemistry assays. It is designed to provide consistent and reliable reference points for various biochemical tests.
Clinical Applications
This device is commonly used in clinical laboratories to ensure the accuracy of test results for enzymes, calcium, creatinine, and other biochemical markers. It is essential for maintaining inter-laboratory comparability and standardization.
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 clinical chemistry.
Reported Outcomes
Published studies report that the Abbott Lyophilized Assayed Chemistry Control effectively standardizes test results across different laboratories, reducing inter-laboratory and inter-method variability. It has been shown to improve the accuracy of enzyme and biochemical marker measurements.
Safety Profile
Reported complications include no significant adverse events associated with the use of this device. The studies primarily focus on its efficacy in standardization rather than safety concerns.
Evidence Limitations
The evidence is limited by the lack of recent large-scale studies specifically focused on this device. Further research is needed to explore its long-term impact on clinical outcomes and to validate its efficacy in newer assay technologies.
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?
The device is indicated for use in clinical laboratories to ensure the accuracy and reliability of biochemical assays, particularly for enzymes, calcium, and creatinine.
What outcomes have been reported in clinical studies?
Studies have reported that the device effectively reduces variability in test results across laboratories, enhancing the accuracy of biochemical measurements.
What complications have been reported?
No significant complications have been reported in the studies. The focus has been on the device's role in standardization rather than safety issues.
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.