CRYOCHECK CLOT APCR
Device Facts
| Record ID | K060284 |
|---|---|
| Device Name | CRYOCHECK CLOT APCR |
| Applicant | Precision Biologic, Inc. |
| Product Code | GGW · Hematology |
| Decision Date | May 10, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7925 |
| Device Class | Class 2 |
Indications for Use
The Sysmex XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.
Device Story
Sysmex XS series (XS-100i, XS-800i) are automated hematology analyzers for clinical laboratories. System comprises main unit (aspiration, dilution, mixing, analysis), auto-loader (XS-1000i only), and Information Processing Unit (IPU) for data processing and operator interface. Analyzers process whole blood samples via sampler, capillary, or manual modes. Principles of operation include Sheath Flow DC detection for RBC/PLT, semiconductor laser flow cytometry for WBC differential, and SLS-hemoglobin method for HGB. Light scatter (forward, lateral) and lateral fluorescence are converted to electrical pulses for cell characterization. System provides 21 CBC parameters. Operators use IPU to review results, which support clinical hematological assessment. Calibration and quality control (X-bar, L-J) ensure analytical performance. Benefits include automated, high-throughput blood cell counting and differential analysis.
Clinical Evidence
Clinical testing performed at Precision BioLogic and a US university hospital-based laboratory. Comparison against predicate device using 207 clinical samples from the target population. Results showed a correlation of R = 0.960. The device demonstrated identical sensitivity and specificity to the predicate.
Technological Characteristics
Clot-based assay; frozen format. Reagents: Activator Reagent (APC-AR) and Russell's viper venom reagent (APC-RV). Principle: dRVVT-based functional clotting assay. Compatible with automated 2-stage clotting test systems. No factor V deficient plasma required.
Indications for Use
Indicated for screening resistance to activated protein C in citrated human plasma from individuals with the factor V Leiden mutation.
Regulatory Classification
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
Predicate Devices
Related Devices
- K971222 — CRYO CHECK APC RESISTANT PLASMA · Precision Biologicals, Inc. · Aug 19, 1997
- K042762 — PEFAKIT APC-R FACTOR V LEIDEN · Pentapharm , Ltd. · Dec 22, 2004
- K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S · Chromogenix AB · Dec 23, 1996
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE
A. 510(k) Number: K060656
B. Purpose for Submission: Traditional 510(k)
C. Manufacturer and Instrument Name: Sysmex America, Inc. Sysmex® XS Automated Hematology Analyzer series (XS-100i and XS-800i).
D. Type of Test or Tests Performed: 21 Complete Blood Count analysis parameters in whole blood.
E. System Descriptions:
1. Device Description: The XS is an automated hematology analyzer which consists of three principal units: (1) Main unit which aspirates, dilutes, mixes and analyzes which blood samples; (2) Auto Loader on the XS-1000i that supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The XS-1000i and XS-800i are the same instruments except that the XS-1000i has the ability to install an auto loader and the XS-800i uses a manual mode only.
2. Principles of Operation: The XS performs hematology analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method. Blood cells pass through the aperture of the detector surrounded by a sheath fluid using the sheath flow method. The principle of flow cytometry is also used. A semiconductor laser beam is emitted to the blood cells passing through the flow cell. The forward scattered light is received by the photodiode, and the lateral scattered light and lateral fluorescent light are received by the photo multiplier tube. This light is converted into electrical pulses, thus making it possible to obtain blood cell information. Hemoglobin is measured with the SLS-hemoglobin method using Sodium Lauryl Sulfate, which is an analysis method used in previous Sysmex instrumentation.
3. Modes of Operation: Sampler Mode, Capillary Mode, and Manual Mode with XS-1000i and Manual Mode and Capillary Mode with XS-800i.
4. Specimen Identification: Barcode only with XS-1000i when Sampler is connected.
5. Specimen Sampling and Handling: Sampler Mode, Capillary Mode, and Manual Mode with XS-1000i and Manual Mode and Capillary Mode with XS-800i.
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6. Calibration: Automatic and manual calibration using fresh normal blood.
7. Quality Control: Commercial control blood is used and analyzed using X-bar control and L-J (Levy-Jennings) Control programs.
8. Software: Comprehensive software documentation at a Moderate Level of Concern was provided by Sysmex.
FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X or No ☐
## F. Regulatory Information:
1. Regulation section: 21 CFR 864.5220. Automated differential cell counter
2. Classification: Class II
3. Product code: GKZ
4. Panel: Hematology (81)
## G. Intended Use:
1. Indication(s) for Use: The Sysmex XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.
2. Special Conditions for Use Statement(s): N/A
## H. Substantial Equivalence Information
1. Predicate Device Name(s) and 510(k) numbers:
Sysmex XT-Series: K021241, Sysmex XE-2100: K992875
2. Comparison with Predicate Device:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Automated blood cell analyzer. | XT-Series and XE-2100: Same. |
| Sample Type | Whole Blood | XT-Series and XE-2100: Same |
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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Bar Code | Yes | XT-Series and XE-2100: Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample Volume | 20μL, Auto loader mode 20μL, Manual mode 20μL, Capillary dilution | XT-Series: 150μL, Cap piercer mode 85μL, Manual mode 40μL, Capillary dilution XE-2100: 200μL, Cap piercer mode 130μL, Manual mode 40μL, Capillary dilution |
| Parameters | WBC, Neut%/#, Lymph%/#, Mono%/#, Eos%/#, Baso%/#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV | XT-Series: Same plus: RET%/#, IRF XE-2100: Same plus: NRBC%/#, RET%/#, IRF |
| Principles | RBC, PLT: DC detection method, WBC: Fluorescent Flow Cytometry-WBC Diff channel using semiconductor laser, HGB: SLS-Hgb method. | XT-Series: RBC, PLT: DC detection method, WBC: Flow Cytometry method using semiconductor laser detection method, HGB: SLS-Hgb method XE-2100: RBC, PLT: Sheath-flow DC detection method, WBC: Flow Cytometry method using semiconductor laser detection method, HGB: SLS-Hgb method. |
| QC System | L-J: 20 files with 180 points per file. | XT-Series: L-J: 20 files with 300 points per file. XE-2100: L-J: 10 files with 300 points per file. |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| # of tests/hour | Approx. 60 | XT-Series: Approx 80 XE-2100: Approx 113-150 |
I. Special Control/Guidance Document Referenced (if applicable): Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells: final Guidance for Industry and FDA, issued on December 4, 2001.
# J. Performance Characteristics:
1. Analytical Performance:
a. Accuracy: Table 1: XS vs. XT
| Parameters | Correlation (r) | Regression (r2) | Regression Equation | Number of Samples |
| --- | --- | --- | --- | --- |
| WBC | 1.00 | 0.9979 | y=0.9438x+0.754 | 609 |
| RBC | 1.00 | 0.9951 | y=1.0049x-0.0492 | 609 |
| HGB | 1.00 | 0.9966 | y=1.0119x0.2155 | 609 |
| HCT | 1.00 | 0.9941 | y=1.0163x-0.7441 | 609 |
| MCV | 0.99 | 0.9887 | y=1.000x+0.2805 | 609 |
| MCH | 0.99 | 0.9772 | y=0.9882+0.3751 | 609 |
| MCHC | 0.95 | 0.8951 | y=0.9459+1.6856 | 609 |
| PLT | 1.00 | 0.9948 | y=0.9885x-4.6694 | 609 |
| RDW-SD | 0.99 | 0.9784 | y=0.9767x+0.8594 | 607 |
| RDW-CV | 0.99 | 0.9891 | y=1.0111x-0.2426 | 607 |
| MPV | 0.82 | 0.6774 | y=0.9247x+0.9571 | 574 |
| Neut% | 1.00 | 0.9966 | y=1.0219x+0.0023 | 579 |
| Lymph% | 1.00 | 0.9992 | y=0.9694x-0.064 | 581 |
| Mono% | 0.98 | 0.9702 | y=0.9792x+0.0584 | 579 |
| Eos% | 0.98 | 0.9668 | y=1.0474x-0.0036 | 595 |
| Baso% | 0.45* | 0.2032 | y=0.3312x+0.0261 | 594 |
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*The lower r-value on the basophile% parameter is typically lower than the other parameters due to the low frequency of the basophile cell type.
b.Precision/Reproducibility:
Table 2: Within Run Precision using blood samples (CLSI EP5)
| N=20 Samples | WBC | RBC | HGB | HCT | MCV | MCH | MCHC | PLT |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| #1 Mean | 8.73 | 3.93 | 12.2 | 37.0 | 94.2 | 31.1 | 33.0 | 208.1 |
| SD | 0.14 | 0.03 | 0.1 | 0.4 | 1.0 | 0.2 | 0.4 | 3.8 |
| CV% | 1.65 | 0.72 | 0.6 | 1.0 | 1.0 | 0.6 | 1.3 | 1.8 |
| | | | | | | | | |
| #2 Mean | 7.45 | 4.89 | 14.8 | 44.5 | 91.2 | 30.3 | 33.2 | 223.3 |
| SD | 0.13 | 0.03 | 0.1 | 0.4 | 1.1 | 0.1 | 0.4 | 4.1 |
| CV% | 1.74 | 0.58 | 0.5 | 0.8 | 1.2 | 0.5 | 1.3 | 1.8 |
| | | | | | | | | |
| #3 Mean | 8.22 | 4.81 | 13.4 | 41.1 | 85.8 | 27.9 | 32.6 | 145.9 |
| SD | 0.11 | 0.02 | 0.0 | 0.4 | 0.8 | 0.1 | 0.4 | 4.3 |
| CV% | 1.36 | 0.38 | 0.4 | 0.9 | 0.9 | 0.5 | 1.1 | 2.9 |
| | | | | | | | | |
| #4 Mean | 7.45 | 4.50 | 13.1 | 40.7 | 90.5 | 29.0 | 32.1 | 226.3 |
| SD | 0.12 | 0.03 | 0.1 | 0.4 | 1.1 | 0.2 | 0.5 | 3.1 |
| CV% | 1.55 | 0.73 | 0.5 | 1.0 | 1.2 | 0.7 | 1.4 | 1.4 |
| | | | | | | | | |
| #5 Mean | 6.58 | 3.94 | 13.2 | 39.0 | 99.0 | 33.4 | 33.8 | 382.4 |
| SD | 0.13 | 0.05 | 0.1 | 0.5 | 0.9 | 0.4 | 0.4 | 6.1 |
| CV% | 2.03 | 1.22 | 0.4 | 1.3 | 0.9 | 1.1 | 1.3 | 1.6 |
| Avg CV% | 1.67 | 0.73 | 0.5 | 1.0 | 1.0 | 0.7 | 1.3 | 1.9 |
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c. Linearity: Linearity was evaluated using a series of dilutions of residual patient material. Replicates were measured at each level and represented the range of linearity.
Table 3 Linearity
| Parameter | Range Tested | Units | r2 | r | Slope | Intercept |
| --- | --- | --- | --- | --- | --- | --- |
| WBC | 0-1.110 | x103/μL | 0.9975 | 1.00 | 1.0195 | 0.0034 |
| | 0.080-172.40 | x103/μL | 0.9993 | 1.00 | 1.0103 | 0.3659 |
| | 0.015-448.63 | x103/μL | 0.9997 | 1.00 | 0.9963 | 1.0965 |
| | | | | | | |
| RBC | 0-8.93 | x106/μL | 0.999 | 1.00 | 1.0096 | 0.0393 |
| | | | | | | |
| HGB | 0-26.4 | g/dL | 0.9992 | 1.00 | 1.0132 | 0.0009 |
| | | | | | | |
| HCT | 0-74.9 | % | 0.9959 | 1.00 | 1.0999 | 0.7802 |
| | 0.4-64.9 | % | 0.9919 | 1.00 | 1.0103 | 1.7469 |
| | | | | | | |
| PLT | 0-117 | x103/μL | 0.9997 | 1.00 | 0.9949 | 1.3913 |
| | 3--5670 | x103/μL | 0.9981 | 1.00 | 0.9876 | -41.069 |
# d. Carryover:
Carryover was evaluated by assaying a sample with high concentration three consecutive times followed immediately by testing a low sample consecutively 3 times. This is the method in Guidelines for the valuation of blood cell analyzers including those used for differential leukocyte and reticulocyte counting and cell marker applications. ISLH, January 14, 1994.
Table 4: Carryover
| Parameter | % Carryover | % Carryover | Manufacturer Specifications |
| --- | --- | --- | --- |
| WBC | 0.01 | -0.02 | ≤1% |
| RBC | 0.00 | -0.21 | ≤1% |
| HGB | 0.00 | 0.59 | ≤1% |
| HCT | 0.00 | 0.00 | ≤1% |
| PLT | 0.05 | 0.00 | ≤1% |
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e. Interfering Substances:
N/A
2. Other Supportive Instrument Performance Data Not Covered Above:
Reference Values: Normal specimens from this study fell within these ranges.
Table 5: XS Reference Range Verification
| Parameter | Females n=133 | Males n=182 | Units |
| --- | --- | --- | --- |
| WBC | 3.98-10.04 | 4.23-9.07 | x10^3/μL |
| Neut% | 34.0-71.1 | 34.0-67.9 | % |
| Lymph% | 19.3-51.7 | 21.8-53.1 | % |
| Mono% | 4.7-12.5 | 5.3-12.2 | % |
| Eo% | 0.7-5.8 | 0.8-7.0 | % |
| Baso% | 0.1-1.2 | 0.2-1.2 | % |
| Neut# | 1.56-6.13 | 1.78-5.38 | x10^3/μL |
| Lymph# | 1.18-3.74 | 1.32-3.57 | x10^3/μL |
| Mono# | 0.24-0.36 | 0.30-0.82 | x10^3/μL |
| Eo# | 0.04-0.36 | 0.04-0.54 | x10^3/μL |
| Baso# | 0.01-0.08 | 0.01-0.08 | x10^3/μL |
| RBC | 3.93-5.22 | 4.63-6.08 | x10^6/μL |
| HGB | 11.2-15.7 | 13.7-17.5 | g/dL |
| HCT | 34.1-44.9 | 40.1-51.0 | % |
| MCV | 79.4-94.8 | 79.0-92.2 | fL |
| MCH | 25.6-32.2 | 25.7-32.2 | pg |
| MCHC | 32.2-35.5 | 32.3-36.5 | g/dL |
| RDW-CV | 11.7-14.4 | 11.6-14.4 | % |
| RDW-SD | 36.4-46.3 | 35.1-43.9 | fL |
| PLT | 182-369 | 163-337 | x10^3/μL |
# K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
# L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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