SPUNCRIT (MODEL DRC-40)

K961803 · Micro Diagnostics Corp. · GKG · Jul 5, 1996 · Hematology

Device Facts

• Record ID: K961803
• Device Name: SPUNCRIT (MODEL DRC-40)
• Applicant: Micro Diagnostics Corp.
• Product Code: GKG · Hematology
• Decision Date: Jul 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6400
• Device Class: Class 2

Device Story

Spuncrit (Model DRC-40) is a portable, battery-operated micro hematocrit centrifuge. It processes heparinized micro capillary blood samples via centrifugal force (10,000 RPM; RCF=4260) to measure hematocrit. The device features a mechanical cover lock, mechanical brake for cycle interruption, low battery indicator, and electronic malfunction detection. It provides an optically read digital output of hematocrit percentage (range 14% to 57%) and an estimated hemoglobin value (range 12.2 to 18.2 g/dL) for normal ranges. Operated by technicians, nurses, or phlebotomists in clinical settings, the device aids in rapid hematocrit assessment. The digital readout allows healthcare providers to quickly evaluate blood status, facilitating clinical decision-making regarding patient hematocrit levels.

Clinical Evidence

Bench testing and comparative performance studies conducted. Comparative study (N=45 per site) across four sites (lab, two physician offices, blood bank) showed high correlation (R=0.99) with predicate. Precision studies (within-run and between-run) performed using assayed whole blood controls (Streck) and whole blood samples over 7-13 day intervals. Results demonstrated consistent performance across hematocrit ranges (14% to 57%).

Technological Characteristics

Portable, battery-operated micro hematocrit centrifuge. Operates at 10,000 RPM with RCF of 4260 and 1.5-inch rotor radius. Uses plastic disposable micro capillary holders. Features mechanical cover lock, mechanical brake, and digital optical readout. Electronic malfunction detection included. No specific material standards cited.

Indications for Use

Indicated for the determination of hematocrit levels in whole blood samples. Intended for use in clinical laboratories, physician offices, and blood banks by trained personnel (technicians, nurses, or phlebotomists). The device is not indicated for use with severely hemolyzed blood or for the estimation of hemoglobin in patients with genetic anemias or anemia caused by chronic disease states.

Regulatory Classification

Identification

A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

Predicate Devices

• Compur M1100 Minicentrifuge (K850391)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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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

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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

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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.

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# 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.

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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 | |

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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).

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# 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.

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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.