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510(k) Data Aggregation
(210 days)
The Sight OLO is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples collected in KyEDTA blood collection tubes, or fingertip samples collected using the Sight OLO test kit micro-capillary tubes.
When used with the Sight OLO cartridge, the Sight OLO enumerates the following CBC parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, RDW, PLT, NEUT%#, LYMPH %#, MONO %#, EOS%#, and BASO%/#.
The Sight OLO is indicated for use in clinical laboratories to identify and classify one or more of the formed elements of blood in children 3 months and above, adolescents and adults.
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface.
The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%#, LYMPH %#, MONO %/#, EOS%# and BASO%#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study Category | Measurand | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Method Comparison | WBC, RBC, PLT, HGB, HCT, MCV, RDW, MCH, MCHC, NEUT%, NEUT#, LYMPH%, LYMPH#, MONO%, MONO#, EOS%, EOS#, BASO%, BASO# | Correlation, bias, slope, and intercept (and their 95% two-sided confidence intervals) met pre-specified criteria. | All measurands met the pre-specified acceptance criteria for correlation, bias, slope, intercept (and the 95% two-sided confidence interval (CI) around the slope and intercept). (See Table 1 for specific values for each measurand). |
| Repeatability | All measurands | All measurands in all tested ranges met predefined acceptance criteria for mean, standard deviation (SD), and coefficient of variation (CV). | All measurands in all tested ranges met the predefined acceptance criteria. (See Table 2 for specific values for each measurand across target ranges). |
| Reproducibility | All measurands | All components of variation (within-run, between-run, between-day, between-instrument, between-site, total precision) met predefined acceptance criteria for SD and %CV. | All components of variation that were calculated met the pre-defined acceptance criteria. (See Table 3 for specific values for each measurand across low, normal, and high levels). |
| Detection Limits (LoB, LoD, LoQ) | WBC, PLT, HGB | LoB defined as 95th percentile of study variable. LoD determined mathematically. LoQ defined as lowest concentration (≥LoD) where total error (TE) accuracy goals were satisfied. Test results met these definitions. | WBC: LoB = 0.04 x 10³/μL, LoD = 0.17 x 10³/μL, LoQ = 0.18 x 10³/μL |
| PLT: LoB = 8.00 x 10³/μL, LoD = 11.00 x 10³/μL, LoQ = 13.40 x 10³/μL | |||
| HGB: LoB = 0 g/dL, LoD = 3.9 g/dL, LoQ = 3.9 g/dL. (All met acceptance criteria). | |||
| Linearity | HGB, PLT, WBC | The final linearity range was determined as the intersection of the results from three instruments, and no lower than the LoD. | HGB: (3.9-21.75) g/dL |
| PLT: (18-1028.5) x 10³/μL | |||
| WBC: (0.18-100.13) x 10³/μL. (All met acceptance criteria). | |||
| Analytical Specificity/Interference | RBC, WBC, HGB, HCT, PLT | No significant interference for D-Glucose, Bilirubin F, Bilirubin C, Chyle, Hemolytic Hemoglobin, Intralipids at specified concentrations. No interference from RBC fragments, high leukocytosis, and high thrombocytosis. | Results demonstrated no significant interference from D-Glucose, Bilirubin F (except for WBC above 8.86 mg/dL), Bilirubin C, Chyle (except for PLT above 530 FTU), Hemolytic Hemoglobin, and Intralipids within tested concentrations. No interference from abnormal specimen conditions. |
| Sample Stability | All measurands | Supports a sample stability claim of 8 hours from blood collection at room temperature, with RDW specifically 4 hours. | Data support a sample stability claim of 8 hours from blood collection at room temperature for all Sight OLO measurands, with RDW having a stability of 4 hours. |
| Test Kit Shelf-Life | Functional and analytical tests | Met predefined acceptance criteria at defined time points. Initial shelf life of 6 months. | Functional and analytical tests were conducted and results met the predefined acceptance criteria. Initial shelf life set at 6 months. Ongoing study with 3 lots (4, 8, 12, 18, 24, 26, 30, 36, 38 months). |
| Transportation Stability | Device and Test Kit | Device maintains calibration and functional specifications. Test kit met all acceptance criteria for functionality and expected analytical results. | The Sight OLO device maintains its calibration and functional specifications. The Sight OLO test kit met all acceptance criteria for functionality and expected analytical results. |
| Flagging Study | Sensitivity and Specificity | Met predefined acceptance criteria. | Sensitivity (PPA): 93.0% |
| Specificity (NPA): 80.6% | |||
| Overall Agreement: 86.5% (Met predefined acceptance criteria). | |||
| Adult and Pediatric Reference Intervals | All measurands | Adults: Reference intervals calculated for each measurand. Pediatrics: Supports validity of pre-established pediatric reference intervals. | Adult reference intervals were calculated. Results supported the validity of pre-established pediatric reference intervals. |
| Matrix Comparison (Capillary vs. Venous) | All applicable measurands | Comparable performance characteristics for capillary and venous whole blood specimens. | The results show comparable performance characteristics for capillary and venous whole blood specimens. |
| Matrix Comparison (Capillary Microtube vs. Sight OLO Test Kit Micro-capillaries) | All applicable measurands | Comparable performance between K2EDTA anticoagulated microtube capillary samples and 2-drop fingertip samples. | The results of the regression and bias analysis showed comparable performance between the K2EDTA anticoagulated microtube capillary samples and the 2-drop fingertip samples. |
2. Sample Size Used for the Test Set and Data Provenance:
- Method Comparison Study: 679 residual clinical K₂EDTA whole blood samples.
- Provenance: Collected from both adults (≥22 years old) and pediatric patients (3 months to 21 years old) at three (3) US sites. The majority were venous samples; a few pediatric samples were capillary whole blood. The study included normal and pathological samples, covering an age range of 3 months to 94 years old. 32% were pediatric samples. Consisted of 355 males (52%) and 324 females (48%). This was a retrospective study using residual clinical samples.
- Repeatability Study: Minimum of 11 samples per site, covering the laboratory reference range and medical decision levels for HGB, PLT, WBC, and upper range for RBC, HGB, WBC, and PLT.
- Provenance: Residual K₂EDTA whole blood samples. Performed at 3 US sites.
- Reproducibility Study: 3 lots of commercial control material (low, normal, high concentrations). For a total of 240 measurements per level of control material (presumably 4 replicates x 2 runs/day x 5 days x 2 instruments/site x 3 sites, though the exact breakdown to reach 240/level is not fully detailed).
- Provenance: Commercial control material. Conducted at 3 sites, including 2 US sites.
- Detection Limits (LoB, LoD, LoQ):
- LoB: Preserved RBC samples (WBC and PLT), diluent (HGB). Two Sight OLO instruments, two reagent lots, 60 measurements per instrument.
- LoD and LoQ: Six low concentration samples (manipulated concentrated and diluted venous blood samples), each measured 10 times, for a total of 60 repeated measurements per test. This was repeated for a different test reagent lot (another 60 measurements).
- Provenance: Manipulated venous blood samples for LoD/LoQ.
- Linearity Studies: Ten (10) venous whole blood samples manipulated to create linearity panels. Seven concentrations for WBC and PLT, ten for RBC and HGB. Each concentration scanned in duplicate. Repeated on three OLO devices.
- Analytical Specificity/Interference Study: Not explicitly stated as a sample size of patient samples, but implied various samples manipulated with interferents.
- Sample Stability Study: 10 freshly collected venous whole blood samples (7 normal, 3 around medical decision levels).
- Test Kit Shelf-Life: Three lots of test kits.
- Transportation Studies: Not specified in terms of sample size, but indicates testing of the physical device and test kits.
- Flagging Study: 208 samples.
- Provenance: Collected at 3 clinical study sites.
- Adult Reference Intervals Study: 240 (120 male and 120 female) apparently healthy adults.
- Provenance: K₂EDTA venous whole blood samples collected from apparently healthy adults (≥22 years) at a single US site. This was a prospective study.
- Pediatric Reference Intervals Study: 80 apparently healthy pediatric subjects (20 per subpopulation: baby (3-23 months), child (2-
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