Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aina HbA1c Monitoring System 2

K-Number: K192987 · 2020-03-26

ApplicantJana Care, Inc.
Decision Date2020-03-26
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Aina HbA1c Monitoring System 2 is a medical device manufactured by Jana Care, Inc.. It received FDA 510(k) clearance on 2020-03-26 under approval number K192987. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aina HbA1c Monitoring System 2?

Aina HbA1c Monitoring System 2 is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Jana Care, Inc.. The 510(k) number is K192987.

When was Aina HbA1c Monitoring System 2 approved by the FDA?

Aina HbA1c Monitoring System 2 received FDA 510(k) clearance on 2020-03-26, under approval number K192987.

What company makes Aina HbA1c Monitoring System 2?

Aina HbA1c Monitoring System 2 is manufactured by Jana Care, Inc..

What is the FDA product code for Aina HbA1c Monitoring System 2?

The FDA product code for Aina HbA1c Monitoring System 2 is LCP.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

Related Devices (Code: LCP)

K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetDiazyme Laboratories K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics K170147Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑