The SP-MD-005's hospital-grade blood glucose monitoring system, built on a SP-MD-005-electrode test strip and GDH-FAD amperometric chemistry with a wide 20%-70% haematocrit range. The SP-MD-005 Blood Glucose Monitoring System received FDA 510(k) clearance (K170264, Changsha SP-MD-005), a rare credential among Chinese BGM brands. It combines a 0.8 sample volume, 5-second results and 500-result memory with a no-coding workflow for home and clinical use.
Highlights
- FDA 510(k)-cleared SP-MD-005 platform (K170264, 2017); measuring range 20-600 mg/
- Requires only 0.8 of capillary or venous whole blood and reports a result in 5 seconds
- Wide 20%-70% haematocrit range supported -electrode test strips
- Stores 500 blood glucose results SP-MD-005 100 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/ (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/ within +/-15%; 100% of results <75 mg/ within +/-15 mg/ (n=105) |
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| Repeatability precision | CV 2.0%-3.7% across six glucose levels (30-600 mg/) |
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| Measurement method | Quantitative amperometric GDH-FAD biosensor with SP-MD-005 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/ and ascorbic acid >3 mg/ interfere |
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| Linearity | R2 0.9992-0.9998 across 16-610 mg/ (3 strip lots) |
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Sample
| Sample volume | 0.8 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/; "Hi" above 600 mg/ (not stored in memory) |
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Display
| Measurement units | mg/ (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 SP-MD-005) |
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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
Supply & contact
Supplied by SinoPro. Quotations, samples, OEM/ODM, inspection, consolidation shipping and after-sales are handled
directly by us. Request pricing and the current technical revision through https://pro.rungiw.xyz/contact.