SPUNCRIT (MODEL DRC-40)

{0} JUN 27 '96 16:18 MICRO DIAGNOSTICS P.4/15 K961803 JUL - 5 1996 PAGE A Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd Rockville MD 20850 RE: K961803, Submission 510(k) Summary for Spuncrit™ Dear Sir or Madam: A summary of the safety and effectiveness information upon which substantial equivalence is based as follows: CLASSIFICATION: Class II Hematocrit Centrifuge PROPRIETARY NAME: Spuncrit™ (Model DRC-40) PRODUCTS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED: ☐ Compur M1100 Minicentrifuge FDA No. K850391 Date: May 10, 1985 SIMILARITIES TO PREDICATE DEVICES CURRENTLY ON THE US MARKET A) Predicate's Name and Manufacturer Address Hematocrit ☐ Compur M1100 Hematocrit System Bayer Diagnostic + Electronic GmbH Steinerstrasse 15 8000 Muchen 70 Germany C/O Hans J. Brouwers and Associates Box 823 Mt Prospect, IL 60056 FDA Reference No. K850391 57 South Commerce Way Bethlehem, PA 18017 Phone: (610) 694-9770 Fax: (610) 694-9990 {1} JUN 27 '96 16:19 MICRO DIAGNOSTICS P.5/15 PAGE B A1) Comparison of Spuncrit™ to Compur (Predicate Device) **MICRO DIAGNOSTICS SPUNCRIT™** - Micro Hematocrit Centrifuge - Operations Manual - Battery Charger - 100 Micro Capillary/ Micro Capillary Holders (heparinized) **COMPUR M1100** - Micro Hematocrit Centrifuge - Operation Manual - Battery Replacement - 100 Capillaries (heparinized) A2) The general features of the Spuncrit™ (Model DRC-40) as compared to the Compur M1100 Minicentrifuge. **SPUNCRIT™** - General Laboratory Device - Methodology: Centrifugal - Measures Hematocrit - Battery Operated - Portable, Hand-Held Safety Features: (1) Cover Lock (2) Low Battery Charge Indicator (3) Motor failure indicator - Optically read (digital readout) **COMPUR M1100** - General Laboratory Device - Methodology: Centrifugal - Measure Hematocrit - Battery Operated - Portable, Hand-held Safety Features: (1) Cover Lock (2) Low Battery Charge Indicator (3) No such feature - Manual, visual read {2} JUN 27 '96 16:19 MICRO DIAGNOSTICS P.6/15 PAGE C - Uses plastic disposable - Range 14% to 57% - Operates at 10,000 RPM - RCF= 4260 - Rotor Radius= 1.5 inches - Uses glass disposable - Range 10% to 80% - Operates at 11,500 RPM - RCF=5396 - Rotor Radius= 1.5 inches A3) The safety features of the Spuncrit™ as compared to the Compur M1100 Minicentrifuge. SPUNCRIT™ COMPUR M1100 COVER LOCK Mechanical lock switch which prevents cover from being opened while centrifuge is in operation MECHANICAL BRAKE In the event the cover is opened prior to the Spuncrit completing the 150 second cycle time the rotor automatically is braked, stopping its rotation within a few seconds LOW BATTERY CHARGE Digital display reads out "C" indicating to operator to charge batteries INSTRUMENT MALFUNCTION In the event of an electronic failure within the instrument the digital readout will not display "8's", as the DRC-40 is running. COVER LOCK Mechanical lock switch which prevents cover from being opened while centrifuge is in operation MECHANICAL BRAKE No such feature LOW BATTERY CHARGE An illuminated red LED indicates batteries need to be replaced INSTRUMENT MALFUNCTION No such feature {3} JUN 27 '96 16:19 MICRO DIAGNOSTICS P.7/15 A4) Comparative data (Performance/Effectiveness Information) between the Spuncrit™ (Model DRC-40) and Compur's M1100 Minicentrifuge. # RESULTS OBSERVED WHEN OPERATING THE SPUNCRIT # COMPARISON DATA An "In Service" to explain the operation of the Spuncrit was performed in each of the locations. Approximately 10 minutes were utilized for training of persons operating the Spuncrit. The comparative study at each location included a total of 45 whole blood samples encompassing three levels ranging from below the normal range to the upper level of the normal range. The samples were split such that each location ran 15 samples at each level. # Spuncrit operating in a Laboratory: - Typical laboratory with technician running the Spuncrit N = 45 Range = 14% Hct to 49% Hct R = .99 Spuncrit operating in Physician Office - #1 - Physician Office employs six Physicians with nurse running Spuncrit. N = 45 Range = 14% Hct to 49% Hct R = .99 Spuncrit operating in Physician Office - #2 - Physician Office employs twelve physicians with a nurse running Spuncrit N = 45 Range = 19% Hct to 53% Hct R = .99  Each data point represents an average of 15 whole blood samples.  Each data point represents an average of 15 whole blood samples.  Each data point represents an average of 16 whole blood samples. {4} JUN 27 '99 10:30 10:40 10:50 10:60 P.8/15 # Spuncrit operating in an Alternate Site: - Blood Bank with a Phlebotomist running the Spuncrit. N = 45 Range = 14% Hct to 49% Hct R = .99  Each data point represents an average of 15 whole blood samples. {5} JUN 27 '96 16:20 MICRO DIAGNOSTICS PAGE F ## PRECISION DATA The precision study was performed within the physician office and another alternate site; a blood bank. Assayed whole blood controls were used in the precision study. Three levels of controls were used. A total of fifteen(15) samples were processed per each level for a total of 45 samples. The range varied from below the normal range to slightly above the normal range for the hematocrit. The study was repeated utilizing assayed whole blood controls from the same lot number seven(7) days after the first study. ## WITHIN RUN PRECISION DATA ### PHYSICIAN OFFICE # 1 | Day One (Hematocrit) | | | | Day Seven (Hematocrit) | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Level 1 | Level 2 | Level 3 | - | Level 1 | Level 2 | Level 3 | | | 18.1 | 30.8 | 46.3 | X | 16.8 | 32.4 | 46.4 | | | .26 | .94 | 1.03 | SD | .77 | .63 | .63 | | | .01 | .03 | .02 | Cv | .04 | .02 | .02 | | | 15 | 15 | 15 | N | 15 | 15 | 15 | | ### PHYSICIAN OFFICE # 2 | Day One (Hematocrit) | | | | Day Seven (Hematocrit) | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Level 1 | Level 2 | Level 3 | - | Level 1 | Level 2 | Level 3 | | | 17.9 | 33.5 | 46.1 | X | 17.4 | 32.7 | 47.7 | | | .70 | .52 | .74 | SD | .64 | .59 | .59 | | | .04 | .02 | .02 | Cv | .04 | .02 | .01 | | | 15 | 15 | 15 | N | 15 | 15 | 15 | | ### ALTERNATE SITE (BLOOD BANK) # 3 | Day One (Hematocrit) | | | | Day Seven (Hematocrit) | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Level 1 | Level 2 | Level 3 | - | Level 1 | Level 2 | Level 3 | | | 18.6 | 33.7 | 47.3 | X | 18.8 | 33.4 | 47.5 | | | .51 | .88 | 1.11 | SD | .68 | .51 | .52 | | | .03 | .02 | .02 | Cv | .04 | .02 | .01 | | | 15 | 15 | 15 | N | 15 | 15 | 15 | | {6} Jun 27 '96 16:21 T.L.KU J.43403 JCS P.10/15 BETWEEN RUN PRECISION DATA Day One and Day 7 (Hematocrit) | Physician Office #1 | X | SD | Cv | N | | --- | --- | --- | --- | --- | | Level 1 | 17.4 | .92 | .05 | 2 | | Level 2 | 31.6 | 1.13 | .04 | 2 | | Level 3 | 46.4 | .07 | <.01 | 2 | | Physician Office #2 | X | SD | Cv | N | | --- | --- | --- | --- | --- | | Level 1 | 17.6 | .35 | .02 | 2 | | Level 2 | 33.1 | .56 | .02 | 2 | | Level 3 | 46.9 | 1.13 | .02 | 2 | | Alternate Site Blood Bank # 3 | X | SD | Cv | N | | --- | --- | --- | --- | --- | | Level 1 | 18.7 | .14 | .01 | 2 | | Level 2 | 33.6 | .21 | .01 | 2 | | Level 3 | 47.4 | .14 | <.01 | 2 | Level 1,2,3 whole blood controls were Para 4 from Steck Laboratories Lot Numbers 61410065, 61410066, and 61410067 respectively. Hematocrit values (%) for Streck controls are 16 +3 or -3, 32 +4 or -4, and 47 +5 or -5 respectively. NOTE: An additional precision study was performed in a typical laboratory with 10 whole blood samples run at each level, a total of five (5) levels were used. The range varied from the lower end of the Spuncrit to the highest end of the Spuncrit. This study was repeated utilizing the same whole blood samples 13 days after the first study. Whole blood samples (5 levels, A through E) were run on Day 1 and Day 13. These samples were prepared from the same lot, run on two different dates (Day 1 and Day 13). {7} P.11/15 # WITHIN RUN PRECISION DATA LABORATORY LOCATION | | DAY ONE(Hematocrit) | | | | DAY 13(Hematocrit) | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | X | SD | Cv | N | X | SD | Cv | N | | LEVEL A | 14.1 | .32 | .02 | 10 | 14.6 | .52 | .04 | 10 | | LEVEL B | 29.3 | .48 | .02 | 10 | 30.3 | .67 | .02 | 10 | | LEVEL C | 37.3 | .48 | .02 | 10 | 36.8 | .92 | .02 | 10 | | LEVEL D | 53.6 | .58 | .01 | 10 | 52.5 | 1.51 | .02 | 10 | | LEVEL E | 56.3 | .68 | .01 | 10 | 56.6 | .52 | .01 | 10 | # BETWEEN RUN PRECISION DATA LABORATORY LOCATION | | DAY ONE and DAY THIRTEEN (Hematocrit) | | | | | --- | --- | --- | --- | --- | | | X | SD | Cv | N | | LEVEL A | 14.4 | .35 | .02 | 2 | | LEVEL B | 29.8 | .71 | .02 | 2 | | LEVEL C | 37.1 | .35 | .02 | 2 | | LEVEL D | 53.1 | .78 | .02 | 2 | | LEVEL E | 56.4 | .21 | <.01 | 2 | CONCLUSION: Based on the above information it is believed that the two products are substantially equivalent and the results provided by the Spuncrit provide the same clinical utility as the Compur M1100 Centrifuge for Hematocrit. {8} JUN 27 30 10:24 10:30 10:40 10:50 P.12/15 PAGE I A6) Limitations of Procedure - Hematocrit - Estimated Hemoglobin There are no known interfering substances that will interfere with the Hematocrit determination performed by the Spuncrit. However, severely hemolyzed blood should not be used in determining the Hematocrit by the Spuncrit. The range of the Spuncrit for Hematocrit is 14% to 57%. The estimated Hemoglobin range is from 12.2 g/dL to 18.2 g/dL. The estimated Hemoglobin only estimates Hemoglobin as a function of the PCV. The estimated Hemoglobin is not representative of anemic problems. As a result the Spuncrit will only estimate the Hemoglobin for normal range only. Genetic Anemias or anemia caused by chronic disease states will not be estimated.