The Gold AQ Plus is Sinocare's hospital-grade blood glucose monitoring system, built on a gold-electrode test strip and GDH-FAD amperometric chemistry with a wide 20%-70% haematocrit range. The Gold AQ Blood Glucose Monitoring System received FDA 510(k) clearance (K170264, Changsha Sinocare, Inc.), a rare credential among Chinese BGM brands. It combines a 0.8 uL sample volume, 5-second results and 500-result memory with a no-coding workflow for home and clinical use.
Highlights
- FDA 510(k)-cleared Gold AQ platform (K170264, 2017); measuring range 20-600 mg/dL
- Requires only 0.8 uL of capillary or venous whole blood and reports a result in 5 seconds
- Wide 20%-70% haematocrit range supported by gold-electrode test strips
- Stores 500 blood glucose results plus 100 control-solution results; no coding required
- Repeatability CV 2.0%-3.7%; 97.9% of lay-user results within +/-15% (n=105)
- Runs on 2 AAA alkaline batteries for about 1,000 tests at 10-40 C and up to 10,100 ft
Technical parameters
Measurement
| Measuring range | 20-600 mg/dL (1.1-33.3 mmol/L) |
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| Test time | 5 seconds |
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| Accuracy (lay-user study) | 97.9% of results >=75 mg/dL within +/-15%; 100% of results <75 mg/dL within +/-15 mg/dL (n=105) |
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| Repeatability precision | CV 2.0%-3.7% across six glucose levels (30-600 mg/dL) |
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| Measurement method | Quantitative amperometric GDH-FAD biosensor with gold electrode |
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| Calibration / coding | Plasma-calibrated, no coding (automatic) |
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| Haematocrit range | 20%-70% |
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| Interference | No significant interference from 28 tested substances; uric acid >10 mg/dL and ascorbic acid >3 mg/dL interfere |
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| Linearity | R2 0.9992-0.9998 across 16-610 mg/dL (3 strip lots) |
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Sample
| Sample volume | 0.8 uL minimum |
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| Sample type | Fresh capillary whole blood (fingertip) and venous whole blood |
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| Test strip storage | 1-30 C, 10-90% RH |
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| Test strip stability | 24 months closed vial; 6 months open vial |
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Memory
| Memory capacity | 500 blood glucose test results + 100 control solution results |
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| Result flags | "Lo" below 20 mg/dL; "Hi" above 600 mg/dL (not stored in memory) |
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Display
| Measurement units | mg/dL (mmol/L equivalent 1.1-33.3 published in worldwide listings) |
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| Control auto-detection | Automatically distinguishes 3 control-solution levels from whole blood |
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Power
| Battery | 2 x AAA alkaline batteries |
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| Battery life | About 1,000 tests |
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Physical
| Meter dimensions | 4.06 x 2.36 x 0.94 in |
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Environment
| Operating conditions | 10-40 C, 10-90% RH (FDA-cleared range) |
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| Altitude | Up to 10,100 ft (tested to 10,207 ft) |
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Regulatory
| FDA classification | Class II, 21 CFR 862.1345, product code NBW, over-the-counter |
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| FDA clearance | 510(k) K170264, cleared 5 October 2017 (Changsha Sinocare, Inc.) |
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| Standard | EN ISO 15197:2015 (per manufacturer product page) |
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Applications
- Home self-monitoring of blood glucose for people with diabetes
- Hospital ward and bedside blood glucose testing by healthcare professionals
- Primary-care clinics and community health centres
- Pharmacy-based diabetes testing and management services
- Diabetes education and structured self-management programmes
- Monitoring during pregnancy where haematocrit is within the 20-70% range (not for neonates)
- Elderly and long-term chronic disease care
- Point-of-care screening in outreach and rural health programmes
Manufacturer
Sinocare Inc., Changsha, Hunan · https://www.sinocare.com
Sinocare was founded in Changsha, Hunan in 2002 and is China's first listed blood glucose meter company (SZSE: 300298). It reports being China's No.1 and the world's No.4 blood glucose monitoring company, with 9 global R&D and manufacturing sites, 187 countries and regions served, over 25 million users and 780+ authorised patents. Its portfolio spans blood glucose meters and strips, continuous glucose monitoring, uric acid, HbA1c and point-of-care analysers.
Sources
- https://www.sinocare.com/en/proinfo_11.html
- https://www.accessdata.fda.gov/cdrh_docs/reviews/K170264.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170264
- https://www.madeinchina.com/mall/show-Sinocare-Diabetic-Test-Strips-Gold-Aq-Plus-Diabetic-Test-Strips_1105764.html