SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

K041240 · Fertility Solutions, Inc. · NRF · Jun 2, 2004 · Hematology

Device Facts

• Record ID: K041240
• Device Name: SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
• Applicant: Fertility Solutions, Inc.
• Product Code: NRF · Hematology
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

The AQC™ Sperm Count and AQC™ Post-vasectomy Quality Controls are intended for monitoring sperm counts performed either manually using commercially available counting chambers or using computer assisted semen analysis (CASA) instruments. The AQC™ Sperm Count and AQC™ Post-vasectomy Quality Controls are intended for use as Quality Control materials having known sperm concentrations. Daily monitoring of the control values establishes intralaboratory parameters for accuracy and precision of the cell counting methods. These products are also available for external laboratory quality control and proficiency testing and as such are sold under the proprietary trade names, AQC™ Sperm Count and AQCTM Post-Vasectomy Proficiency Challenges.

Device Story

AQC™ Sperm Count and Post-vasectomy Quality Controls are liquid, ready-to-use quality control materials containing stabilized human sperm cells and semen in a fortified solution. Preservatives, including formalin, are added to inhibit microbial growth and inactivate infectious agents. The device is used in clinical laboratories to monitor the performance of manual counting chambers or CASA instruments. By providing known sperm concentrations, the controls allow laboratories to establish intralaboratory parameters for accuracy and precision. The product is also used for external quality control and proficiency testing. Healthcare providers use the output (recovered cell counts) to verify that their counting methods are operating within established limits (± 2 standard deviations), ensuring reliable diagnostic results for patients undergoing semen analysis.

Clinical Evidence

No clinical data. Bench testing only; device is a quality control material.

Technological Characteristics

Liquid, ready-to-use suspension of stabilized human sperm cells in a fortified semen matrix. Contains preservatives (formalin). Storage at 2-8°C. No reconstitution or dilution required. Shelf life: 1 year unopened, 6 weeks opened.

Indications for Use

Indicated for use as quality control materials for monitoring sperm counts in clinical laboratories, including manual counting and CASA instruments.

Regulatory Classification

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 Laboratories, Para Tech Plus Retics (K993825)
• Quantimetrix Corp., Synovialscopics Control (K010598)
• R & D Systems, Inc. R & D Body Fluid Control (K020229)
• R & D Systems, Inc. R & D Hematology Control (K010409)

Submission Summary (Full Text)

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

A. 510(k) Number:
K041240

B. Analyte:
Sperm count quality control

C. Type of Test:
Semen analysis sperm count, manual, semi automated, or automated

D. Applicant:
Fertility Solutions, Inc.

E. Proprietary and Established Names:
AQC™ Sperm Count Quality Control, AQC™ Post-Vasectomy Quality Control, AQC™ Sperm Count Proficiency Challenge, AQC™ Post-Vasectomy Proficiency Challenge

F. Regulatory Information:
1. Regulation section:
21 CFR 864.8625 Hematology Quality Control Mixture
2. Classification:
Class II
3. Product Code:
NRF
4. Panel:
Hematology (81)

G. Intended Use:
1. Indication(s) for use:
The AQC™ Sperm Count and AQC™ Post-Vasectomy Quality Controls are intended for monitoring sperm counts performed either manually using commercially available counting chambers or using computer assisted semen analysis (CASA) instruments. The AQC™ Sperm Count and AQC™ Post-Vasectomy Quality Controls are intended for use as quality control materials having known sperm concentrations. Daily monitoring of the control values establishes intra-laboratory parameters for accuracy and precision of the cell counting methods. These products are also available for external laboratory quality control and proficiency testing and as such are sold under the proprietary trade names AQC™ Sperm Count and AQC™ Post-Vasectomy Proficiency Challenges.

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2. Special condition for use statement(s): N/A
3. Special instrument Requirements: N/A

## H. Device Description:

These devices employ a liquid human semen matrix and a stabilized human sperm cell constituent formulation. Each two level control is a ready-to-use liquid requiring no reconstitution or dilution. Preservatives including formalin have been added to inhibit microbial growth. The AQC Sperm Count and AQC Post-Vasectomy Quality Controls are identical to the AQC Sperm Count and AQC Post-Vasectomy Proficiency Challenges except for the volume.

## I. Substantial Equivalence Information:

1. Predicate device name(s):
a. Streck Laboratories, Para Tech Plus Retics (K993825)
b. Quantimetrix Corp., Synovialscopics Control (K010598)
c. R & D Systems, Inc. R & D Body Fluid Control (K020229)
d. R & D Systems, Inc. R & D Hematology Control (K010409)
2. Predicate K number(s):
See above.
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | QC material for cell counts | Same |
| Form | Liquid suspension containing stabilized human cells | Same for a, b, and c above in I. 1. |
| Differences | | |
| Item | Device | Predicate |
| Matrix | Human spermatozoa | Human white blood cells and red cells |
| Form | Liquid suspension containing stabilized human cells. | d. above contains mammalian white blood cells and platelets in addition to human white blood cells and red cells. |
| Levels of control | Two | a. has one level; b and c have two levels; and d has three levels |

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J. Standard/Guidance Document Referenced (if applicable):
Points to Consider for Hematology Quality Control Materials, OIVD, September 30, 1997.

K. Test Principle:
N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
N/A
d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
Representative values as per “Points to Consider” document:
a. Sperm Count Level One=0-30 million / mL
b. Sperm Count Level Two= 30-75 million / mL
c. Post-Vasectomy Negative (absence of sperm)=0 sperm present
d. Post-Vasectomy Positive (presence of sperm)= 0.5-2.0 million / mL

M. Conclusion:
The Fertility Solutions, Inc. AQC Sperm Quality Controls and AQC Post-Vasectomy Quality Controls are substantially equivalent to the predicate devices.