← Product Code [GGM](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGM) · K070334

# R&D SICKLE QC CONTROL (K070334)

_R&D Systems, Inc. · GGM · Mar 29, 2007 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGM/K070334

## Device Facts

- **Applicant:** R&D Systems, Inc.
- **Product Code:** [GGM](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGM.md)
- **Decision Date:** Mar 29, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8625
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.

## Device Story

Sickle QC is a hematology control product used in clinical laboratories to verify the performance of solubility tests for Hemoglobin S. The device consists of processed human red blood cells suspended in an anti-microbial solution, designed to simulate fresh whole blood. It is used by laboratory personnel to ensure that solubility test kits are functioning correctly. By providing a known control sample, the device allows clinicians to validate the accuracy and precision of patient test results, thereby supporting the reliable diagnosis of sickle cell conditions.

## Clinical Evidence

No clinical data. Bench testing only. Stability testing performed on three lots of positive and negative controls confirmed performance as expected over 6 months (closed vial) and 100 days (open vial) at specified temperatures.

## Technological Characteristics

Processed human red blood cells in anti-microbial solution. Form factor: liquid control in vials. Storage: 2-8°C. Shelf life: 6 months (closed), 100 days (open).

## Regulatory Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

## Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Predicate Devices

- Streck Sickle-Chex ([K013316](/device/K013316.md))

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K070334

B. Purpose for Submission:
New Device

C. Measurand:
Hemoglobin S

D. Type of Test:
Qualitative

E. Applicant:
R&D Systems, Inc.

F. Proprietary and Established Names:
R&D Sickle QC Hematology Control

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625, Hematology Quality Control Material
2. Classification:
Class II
3. Product code:
GGM, Control Hemoglobin
4. Panel:
81 (Hematology)

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H. Intended Use:

1. Intended use(s):

R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.

2. Indication(s) for use:

R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.

3. Special conditions for use statement(s):

Not applicable.

4. Special instrument requirements:

Not applicable.

I. Device Description:

R&D Sickle QC Hematology Control is composed of human erythrocytes suspended in a plasma-like fluid with preservatives, supplied as Control 1 (Negative) and Control 2 (Positive). Each vial contains 2.5 mL.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Streck Sickle-Chex

2. Predicate 510(k) number(s):

K013316

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3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | R&D Sickle QC Hematology Control | Streck Sickle-Chex  |
|  Intended use | Used as a sickle cell control to test for the presence of Hemoglobin S in solubility tests. | Same  |
|  Product Description | A positive and negative control composed of human erythrocytes for solubility tests used to detect Hemoglobin S. | A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis.  |
|  Reagent composition | Human erythrocytes suspended in plasma like fluid with preservatives. | Stabilized human red blood cells in a preservative medium.  |
|  Storage | 2-8°C | 2-10°C  |
|  Closed Vial Stability | 6 months | Same  |
|  Open Vial Stability | 100 days | Same  |
|  Parameters | Hemoglobin/Hemoglobin S | Same  |

K. Standard/Guidance Document Referenced (if applicable):

Not applicable.

L. Test Principle:

It is established laboratory practice to use a stable control to monitor the performance of diagnostic tests. This control is composed of stable material that provides a mean of monitoring the presence of sickling hemoglobin S in solubility tests. It is sampled in the same manner as the patient specimen.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

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c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Open and closed vial stability testing was performed on three lots of negative and positive controls (2.5 mL volumes). Vials were stored at 2-8°C for closed vial storage and 15-30° for open vial storage. All controls performed as expected.

Open Vial Stability: 100 days
Closed Vial Stability: 6 months

Value assignment: Human packed red cells are received from vendor and tested once if certification is provided and twice by two different technicians if certification is not provided. A commercial sickle cell test kit is used for this Hemoglobin S testing, and units are processed accordingly to achieve the Control 1 (negative) and Control 2 (positive) product.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

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b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

Sickle QC Hematology Control is designed to be handled in the same manner as a patient specimen. The positive control will appear as a cloudy turbid suspension as described in the reagent test kit instruction for use. The negative control will appear as a nearly transparent solution as described in the reagent test kit instruction for use.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGM/K070334](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGM/K070334)

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