← Product Code [LIN](/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN) · K081164

# D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (K081164)

_Diagnostic Hybrids, Inc. · LIN · Jun 13, 2008 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN/K081164

## Device Facts

- **Applicant:** Diagnostic Hybrids, Inc.
- **Product Code:** [LIN](/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN.md)
- **Decision Date:** Jun 13, 2008
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3175
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Diagnostic Hybrids, Inc. device, D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.

## Device Story

The D3 DFA CMV-IEA Identification Kit is an in vitro diagnostic reagent set used in clinical laboratories to identify CMV in cell culture. Patient samples are inoculated onto susceptible cell monolayers and cultured. After incubation, cells are fixed in acetone and stained with a mixture of two murine monoclonal antibodies (MAbs) directed against CMV immediate early antigen (pp 72), which are directly labeled with Fluorescein Isothiocyanate (FITC). The kit includes control slides, mounting fluid, and PBS concentrate. A healthcare professional examines the prepared cells using a fluorescence microscope. CMV-infected cells exhibit apple-green fluorescent nuclei, while uninfected cells appear red due to an Evans Blue counter-stain. This visual output allows clinicians to confirm the presence of CMV in culture, aiding in the diagnosis of CMV infection. The device is not for direct clinical specimen testing or blood donor screening.

## Clinical Evidence

Clinical performance was evaluated across four sites using 1026 valid specimens (fresh and archival). The study compared the subject device against predicate immunofluorescence assays. Positive percent agreement ranged from 83.3% to 100% across sites, and negative percent agreement ranged from 98.7% to 100%. Analytical sensitivity and specificity were established via bench testing, showing a detection limit of 0.7-TCID50 and no cross-reactivity with a wide panel of viruses and bacteria, except for Staphylococcus aureus (Protein A binding).

## Technological Characteristics

Immunofluorescence assay using murine monoclonal antibodies (IgG1 k isotype) directly labeled with Fluorescein Isothiocyanate (FITC). Includes Evans Blue counter-stain and sodium azide preservative. Requires fluorescence microscopy for visualization. Components: CMV-IEA DFA Reagent, Antigen Control Slides, Mounting Fluid, 40X PBS Concentrate. Standard laboratory cell culture techniques used for viral isolation.

## Regulatory Identification

Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

## Predicate Devices

- Light Diagnostics CMV Direct Immunofluorescence Assay ([K951821](/device/K951821.md))
- Bartels Cytomegalovirus Immediate Early Antigen Indirect Fluorescent Antibody ([K904036](/device/K904036.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number: K081164

B. Purpose for Submission: The 510(k) holder would like to introduce D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit into interstate commerce.

C. Measurand: Human cytomegalovirus (CMV) immediate early antigen (IEA)

D. Type of Test: DFA to detect the presence of CMV immediate early antigen amplified in cell culture using fluoresceinated monoclonal antibodies.

E. Applicant: Diagnostic Hybrids, Inc.

F. Proprietary and Established Names: Diagnostic Hybrids' D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit

G. Regulatory Information:

1. Regulation section: 21CFR 866.3175 Cytomegalovirus serological reagents
2. Classification: Class II
3. Product code: LIN – Antiserum, Conjugated Fluorescent, Cytomegalovirus
4. Panel: Microbiology (83)

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LIN | Class II | 21CFR 866.3175 | Microbiology (83)  |

H. Intended Use:

Intended use(s): The Diagnostic Hybrids, Inc. device, D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).

This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.

2. Indication(s) for use: Same as Intended Use.
3. Special conditions for use statement(s): For prescription use only

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4. Special instrument requirements: Fluorescence microscope with the correct filter combination for FITC (excitation peak = 490 nm, emission peak = 520nm).

I. Device Description:

Two murine derived monoclonal antibodies (MAbs) are used in the Diagnostic Hybrids, Inc. (DHI) device, D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit (CMV-IEA ID Kit), and are directed against CMV immediate early antigen (pp 72). The MAbs used in the Kit have been shown to be highly specific, with no cross-reactivity to other cultured viruses. The MAbs have been labeled by DHI using Fluorescein Isothiocyanate (FITC).

Kit Components

1. CMV-IEA DFA Reagent, 10-mL. One dropper bottle containing a mixture of two murine MAbs directed against CMV immediate early antigen (pp 72). The MAbs are both IgG1 (k) isotype. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as preservative.
2. CMV Antigen Control Slides, 5-slides. Individually packaged control slides containing wells with cell culture derived positive and negative control cells. Each slide contains one Negative well of uninfected cells and one Positive well of CMV infected cells. Each slide is intended to be stained only one time.
3. Mounting Fluid, 7-mL. One dropper bottle of an aqueous, buffered, stabilized solution of glycerol (ph 8.2 ± 0.2) and 0.1% sodium azide.
4. 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in a phosphate buffered saline (PBS) solution.

J. Substantial Equivalence Information:

1. Predicate device names:
a. K951821, Light Diagnostics CMV Direct Immunofluorescence Assay (Millipore)
b. K904036, Bartels Cytomegalovirus Immediate Early Antigen Indirect Fluorescent Antibody (Trinity Biotech PLC)

2. Predicate K numbers:
a. K951821
b. K904036

1. Comparison with predicate:

The Diagnostic Hybrids, Inc. device, D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit, has been compared directly to Bartels Cytomegalovirus Immediate Early Antigen Kit and the Light Diagnostics CMV Direct Immunofluorescence Assay as the legally marketed devices. The technology used in all devices is based on a standard immunofluorescence assay technique utilizing fluorescein-labeled MAbs and viral isolation in cell culture. A summary is provided in Table 1 below:

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|  TABLE 1: Technological Characteristics Compared Among DHI Device and Predicate Devices  |   |   |   |
| --- | --- | --- | --- |
|  Characteristic | Subject Device DHI | Predicate Bartels (K904036) | Predicate Light Diagnostics (K951821)  |
|  Immediate Early Antigen | X | X | X  |
|  MAb Directly Labeled with Fluorescein | X | -- | X  |
|  MAb Indirect labeled with Fluorescein (requires labeled secondary anti-mouse antibody) | -- | X | --  |
|  Culture Confirmation | X | X | X  |
|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Comparison Device  |
|  tended Use | For the qualitative detection of CMV in inoculated cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Performance has not been established with direct patient specimens. | a. Light Diagnostics b. Bartels  |
|  asic principle | Direct Fluorescent Antibody (DFA) test - Immunofluorescence using fluoresceinated MAbs | a. Light Diagnostics  |
|  ntibody ntigen | Murine monoclonal antibodies against epitopes of CMV | a. Light Diagnostics b. Bartels  |
|  Instrumentation (required but not provided) | Fluorescence microscope with filter combination for fluorescein (excitation peak = 490 nm, emission peak = 520nm). | a. Light Diagnostics b. Bartels .  |

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

# L. Test Principle:

The  $\mathrm{D}^3$  DFA Cytomegalovirus Immediate Early Antigen Identification Kit uses a blend of CMV-IEA antigen-specific murine MAbs that are directly labeled with fluorescein for the rapid detection of CMV-IEA in cell culture. Clinical specimens are inoculated into permissible cultured cell monolayers. These cells are fixed in acetone 1- to 4-days postinoculation. The CMV-IEA DFA Reagent is added to the cells to detect the presence of

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any CMV-IEA antigens present. After incubating for 15 to 30 minutes at 35° to 37°C, the stained cells are washed with the supplied Phosphate Buffered Saline (PBS) and, using the supplied Mounting Fluid, processed further for examination using a fluorescence microscope equipped with the correct filter combination for Fluorescein Isothiocyanate (FITC) at a magnification of 200-400X. Virus infected cells will contain bright apple-green fluorescent nuclei while uninfected cells will contain no apple-green fluorescence but will fluoresce red from the Evan's Blue.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

a. Precision/Reproducibility: Not applicable
b. Linearity/assay reportable range: Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Not applicable
d. Analytical Sensitivity:

Analytical sensitivity was studied for purposes of demonstrating the effectiveness of the D³ CMV-IEA DFA Reagent with that of a comparator device. This was done by first inoculating two 96-well cell culture plates (Hs27) with CMV diluted to a value of 1-TCID₅₀ and incubating at 37°C for 48 hours; then, one plate was stained with the subject D³ CMV-IEA DFA Reagent and the other plate was stained using the CMV-IEA DFA Reagent from the comparator device. This assay was performed three times, with an average of 35.3 ± 2.3 positive wells out of a total 96 wells detected with the subject, and an average of 38.3 ± 2.1 positive wells out of a total 96 wells with the predicate. These results were not statistically different by a paired t-test.

Detection limit for the subject device CMV-IEA ID Kit was addressed under the conditions: CMV, at a starting concentration 350-TCID₅₀ per mL, was serially diluted to a final value of 0.7-TCID₅₀ per mL using 2-fold dilutions. Each dilution was inoculated into confluent monolayers of Hs27 cells contained in multi-well plates, centrifuged at 700 × g for 60 minutes and incubated at 35° to 37°C for 48 hours. The subject CMV-IEA ID Kit or the comparator device was used to stain 3 monolayers of each viral dilution according to the respective device's product insert. The number of positive cells per well was counted. The experiment was performed three times. The results suggest that the detection limit of both fluorescent antibody stains are comparable, with 0.7-TCID₅₀ as the minimum viral dilution detected, as indicated by at least one well having no detectable infection. These results were not statistically different by a paired T-test.

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# Analytical Specificity (Cross-reactivity Testing):

The  $\mathrm{D}^3$  DFA Cytomegalovirus Immediate Early Antigen Identification Kit DFA Reagent was tested for cross-reactivity against a wide variety of cells and microorganisms. Stringent conditions for cross-reactivity testing were achieved by using a high concentration of the CMV-IEA DFA Reagent and relatively high titers of microorganisms. The DFA Reagent was prepared at 2X the concentration that is provided in the kit. No cross-reactivity was observed for 58 virus strains or for 20 host culture cell types. Twenty-five (25) bacterial cultures, one yeast culture and three bacterial (Chlamydia sp.) and one protozoan commercially available slides, were stained and examined for cross-reactivity, including Staphylococcus aureus, a protein-A-producing bacterium. Staining of S. aureus appeared as small points of fluorescence (see Limitations of Procedure). Fifty-eight (58) virus strains were tested for cross-reactivity. Depending on the particular virus, 140 to  $1,400\mathrm{TCID}_{50}$  were inoculated into shell vial culture and incubated for 24 to 48 hours, to yield a  $1+$  to  $3+$  infection, processed and stained with the 2X DFA Reagent according to the procedure as detailed in this product insert. No cross-reactivity was observed for the viruses listed below

|  Organism | Strain or Type | Inoculum (TCID50)  |
| --- | --- | --- |
|  Adenovirus | Type 1 | 1,400  |
|  Adenovirus | Type 3 | 1,400  |
|  Adenovirus | Type 5 | 1,400  |
|  Adenovirus | Type 6 | 1,400  |
|  Adenovirus | Type 7 | 1,400  |
|  Adenovirus | Type 8 | 1,400  |
|  Adenovirus | Type 10 | 1,400  |
|  Adenovirus | Type 13 | 1,400  |
|  Adenovirus | Type 14 | 1,400  |
|  Adenovirus | Type 31 | 1,400  |
|  Influenza A | Aichi | 1,400  |
|  Influenza A | Malaya | 1,400  |
|  Influenza A | Hong Kong | 1,400  |
|  Influenza A | Denver | 1,400  |
|  Influenza A | Port Chalmers | 1,400  |
|  Influenza A | Victoria | 1,400  |
|  Influenza A | New Jersey | 1,400  |
|  Influenza A | PR | 1,400  |
|  Influenza A | WS | 1,400  |
|  Influenza B | Hong Kong | 1,400  |
|  Organism | Strain or Type | Inoculum (TCID50)  |
| --- | --- | --- |
|  RSV | Long | 1,400  |
|  RSV | Wash | 1,400  |
|  RSV | 9320 | 1,400  |
|  Parainfluenza 1 | C-35 | 1,400  |
|  Parainfluenza 2 | Greer | 1,400  |
|  Parainfluenza 3 | C 243 | 1,400  |
|  Parainfluenza 4a | M-25 | 1,400  |
|  Parainfluenza 4b | CH19503 | 1,400  |
|  HSV-1 | IF | 140  |
|  HSV-1 | MacIntyre | 140  |
|  HSV-2 | MS | 140  |
|  HSV-2 | Strain G | 140  |
|  VZV | Webster | 140  |
|  VZV | Ellen | 140  |
|  VZV | AV92-3 | 140  |
|  Epstein-Barr | Commercially available slides stained.*  |   |
|  Rubeola  |   |   |
|  Mumps  |   |   |
|  Echovirus | Types 4, 6, 9, 11, 30, 34 | Commercially available slides  |

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|  Organism | Strain or Type | Inoculum (TCID_{50})  |
| --- | --- | --- |
|  Influenza B | Maryland | 1,400  |
|  Influenza B | Mass | 1,400  |
|  Influenza B | Taiwan | 1,400  |
|  Influenza B | GL | 1,400  |
|  Influenza B | Russia | 1,400  |
|  Organism | Strain or Type | Inoculum (TCID_{50})  |
| --- | --- | --- |
|  Coxsackievirus | Types B1, B2, B3, B4, B5, B6 | stained.*  |
|  Poliovirus | Types 1, 2, 3  |   |
|  Influenza A | PR | 1,400  |
| --- | --- | --- |
|  Influenza A | WS | 1,400  |
|  Influenza B | Hong Kong | 1,400  |
|  Influenza B | Maryland | 1,400  |
|  Influenza B | Mass | 1,400  |
|  Influenza B | Taiwan | 1,400  |
|  Influenza B | GL | 1,400  |
|  Influenza B | Russia | 1,400  |
|  Mumps |   |   |
| --- | --- | --- |
|  Echovirus | Types 4, 6, 9, 11, 30, 34 | Commercially available slides stained.*  |
|  Coxsackievirus | Types B1, B2, B3, B4, B5, B6  |   |
|  Poliovirus | Types 1, 2, 3  |   |

Twenty (20) host culture cell types were tested for cross-reactivity. Cell cultures were prepared in shell vial format. Confluent monolayers were stained with the 2X DFA Reagent according to the procedure as detailed in this product insert, then examined for cross-reactivity. No cross-reactivity was observed for the following cell lines

Cell Lines and Viruses Cross-reactivity Testing

|  Organism | Strain or Type | Lot Number | Chlamydiae DFA Reagent | TCID_{50} or CFU  |
| --- | --- | --- | --- | --- |
|  Cell Line | A-549 | C560316 | - | n/a  |
|  Cell Line | BGMK | C530316 | - | n/a  |
|  Cell Line | HEp-2 | C570316 | - | n/a  |
|  Cell Line | HFF (Hs27) | C870315 | - | n/a  |
|  Cell Line | LLC-MK2 | C860316S | - | n/a  |
|  Cell Line | McCoy | C540316 | - | n/a  |
|  Cell Line | MDCK | C830316S | - | n/a  |
|  Cell Line | MRC-5 | C510315A | - | n/a  |
|  Cell Line | MRHF | C440314 | - | n/a  |
|  Cell Line | Mv1Lu | C580317S | - | n/a  |
|  Cell Line | NCI-H292 | C590313S | - | n/a  |
|  Cell Line | pCMK | 470309 | - | n/a  |
|  Cell Line | pRhMK | A490310 | - | n/a  |
|  Cell Line | RD | C760317S | - | n/a  |
|  Cell Line | RhMK II | 490311YS | - | n/a  |
|  Cell Line | RK (passage 1) | C480314PS | - | n/a  |

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Thirty (30) microorganisms, including 25 bacterial cultures, one yeast and three bacterial (Chlamydia sp.) and one protozoan commercially available slides, were stained with the 2X DFA Reagent according to the procedure as detailed in this product insert, then examined for cross-reactivity. Except for Staphylococcus aureus, this was cross-reactive with the CMV-IEA DFA Reagent (see above), all other microorganisms tested negative. Concentrations for each bacterial organism cultured by DHI for cross-reactivity testing were determined from suspensions of the bacteria in PBS by spectrophotometer according to McFarland standards of levels 1.0 and 2.0 (equaling approximately  $3.0 \times 10^{6}$  and  $6.0 \times 10^{6}$  CFU per mL). Slides were prepared with spots of  $0.01\mathrm{-mL}$  of the suspensions to give either  $3.0 \times 10^{4}$  or  $6.0 \times 10^{4}$  per spot. At the same time,  $1\mathrm{-mL}$  of each suspension was plated on an appropriate agar dish for colony confirmation. According to the confirmation agar cultures, initial concentrations of the bacterial organisms in the study ranged from  $6.4 \times 10^{4}$  to  $2.9 \times 10^{7}$  CFU. Results of testing are listed below.

Bacteria, Yeast, and Protozoa Cross Reactivity Testing

|  Organism | Strain or Type | Lot Number | Chlamydiae DFA Reagent | TCID50 or CFU  |
| --- | --- | --- | --- | --- |
|  Bacteria | Acholeplasma laidlawi | 031404 | - | ~1.0e7  |
|  Bacteria | Acinetobacter calcoaceticus | 934332 | - | 9.7e5  |
|  Bacteria | Bordetella bronchiseptica | 031404 | - | 1.8e5  |
|  Bacteria | Bordetella pertussis | 031404 | - | 4.7e6  |
|  Bacteria | Chlamydiophila pneumoniae | CP-0176 | + | Control Slide*  |
|  Bacteria | Chlamydiophila psittaci | FP-12-050218 | + | Control Slide*  |
|  Bacteria | Chlamydia trachomatis | 052705 | + | Control Slide*  |
|  Bacteria | Corynebacterium diphtheriae | 031404 | - | 2.5e6  |
|  Bacteria | Escherichia coli | 335472 | - | 2.6e5  |
|  Bacteria | Gardnerella vaginalis | 3457511 | - | 5.0e5  |
|  Bacteria | Haemophilis influenzae type A | 031404 | - | 9.3e5  |
|  Bacteria | Klebsiella pneumoniae | 031404 | - | 6.4e6  |
|  Bacteria | Legionella pneumophila | 031404 | - | 6.5e4  |
|  Bacteria | Moraxella cartarrhalis | 031404 | - | 6.4e4  |
|  Bacteria | Mycoplasma hominis | 031404 | - | ~1.0e4  |
|  Bacteria | Mycoplasma orale | 031404 | - | ~1.0e4  |

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|  Bacteria | Mycoplasma pneumoniae | 031404 | - | ~1.0e4  |
| --- | --- | --- | --- | --- |
|  Bacteria | Mycoplasma salivarium | 031404 | - | ~1.0e7  |
|  Bacteria | Neisseria gonorrhoeae | 060805 | - | 1.3e6  |
|  Bacteria | Proteus mirabilis | 440498 | - | 2.1e6  |
|  Bacteria | Pseudomonas aeruginosa | 031404 | - | 1.0e7  |
|  Bacteria | Salmonella enteritidis | 3457511 | - | 2.5e6  |
|  Bacteria | Salmonella typhimurium | 363162 | - | 1.8e6  |
|  Bacteria | Staphylococcus aureus | 081100 | + | 1.0e7  |
|  Bacteria | Streptococcus agalactiae | 370784 | - | 9.6e6  |
|  Bacteria | Streptococcus pneumoniae | 031404 | - | 8.0e5  |
|  Bacteria | Streptococcus pyogenes | 031404 | - | 2.9e7  |
|  Bacteria | Ureaplasma urealyticum | 031404 | - | ~1.0e4  |
|  Yeast | Candida glabrata | 992206 | - | 8.7e6  |
|  Protozoa | Trichomonas vaginalis | 410721 | - |   |

f. Assay cut-off: Not applicable

2. Comparison studies:

a. Method comparison with predicate device: A total of 1060 specimens were cultured and stained with one of two comparative devices and the D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit at three external clinical laboratory sites and at the DHI internal laboratory. A total of 34 specimens were excluded from final analysis, resulting in a total of 1026 results reported. Reasons for exclusion were specimen toxicity to cell culture (29), bacterial contamination of cell culture (1), non-specific fluorescence seen prohibiting interpretation (2), and unacceptable specimens (2).

b. Matrix comparison: Not applicable

3. Clinical studies:

Percent Agreement between the D³ DFA Cytomegalovirus Immediate Early Antigen Identification Kit (D³ CMV-IEA ID Kit) and Comparator Devices was calculated for all the above analyzed specimens. [See Table below.]

Overall Comparison of D³ CMV-IEA ID Kit with Comparator Kits

|  Comparator Device  |   |   |
| --- | --- | --- |
|   | + | -  |
|  D³ CMV-IEA ID Kit | + | 100  |
|  - | 4 | 918  |

Total: 1026

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Positive percent agreement (PPA) = 96.1% (100/104), 95% CI 90.5-98.5

Negative percent agreement (NPA) = 99.6% (918/922), 95% CI 98.9-99.8

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

# 5. Expected values/Reference range:

The clinical studies described in Section X ('Specific Performance Characteristics') used only specimens that were collected and cultured for the presence of CMV.

The specimen sources and positivity with the comparison devices are described in the Tables below.

|  Summary of Overall Specimen Source by Site  |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Site | Total | Blood | Body Fluid | Genital | G.I. - upper | G.I. - lower | Resp. - upper | Resp. - lower | Skin/Lesions | Tissue | Urine | Unknown  |
|  1 | 314 | 45 | 16 | 1 | 4 | 12 | 10 | 131 | 1 | 21 | 73 | 0  |
|  2 | 293 | 0 | 0 | 0 | 0 | 0 | 271 | 15 | 0 | 6 | 1 | 0  |
|  3 | 128 | 11 | 8 | 0 | 4 | 4 | 13 | 62 | 2 | 0 | 23 | 1  |
|  4 | 291 | 72 | 16 | 0 | 7 | 0 | 30 | 95 | 1 | 12 | 58 | 0  |
|  Total: | 1026 | 128 | 40 | 1 | 15 | 16 | 324 | 303 | 4 | 39 | 155 | 1  |
|  Blood: blood, buffy coat Body Fluids: fluid, amniotic fluid, central spinal fluid (CSF/CF), pericardial fluid, pleural Genital: Genital G.I. - upper: gastrointestinal (upper), mouth, esophageal, ranula basil G.I. - lower: gastrointestinal (lower), stomach, colon, sigmoid, bowel, stool, pleura Resp. - upper: respiratory (upper), nasal (NS), nasopharyngeal (NP) aspirates, throat, nares Resp. - lower: respiratory (lower), lung, lobes, bronchial, bronchial alveolar lavage (BAL), bronchial washing (BW), brushings, tracheal aspirates (TA), sputum, Skin/Lesions: abdomen, conjunctiva Tissue: biopsy (BX), liver, heart, lymph nodes, brain, bone marrow, Urine: urine Unknown: investigator unable to specify source  |   |   |   |   |   |   |   |   |   |   |   |   |

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The specimen Age/Sex demographics for the specimens cultured are tabulated in the Table below.

|  Age and Gender Distribution  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Age Range | Values are # Positive / Total  |   |   |   |
|   |  Male | Female | Gender Unknown | Total  |
|  0 - 1 month | 0 / 37 | 3 / 17 | 0 / 0 | 3 / 54  |
|  >1 month - 2 years | 31 / 176 | 33 / 151 | 0 / 0 | 64 / 327  |
|  >2 - 12 years | 6 / 34 | 2 / 31 | 0 / 0 | 8 / 65  |
|  >12 - 21 years | 0 / 12 | 0 / 9 | 0 / 0 | 0 / 21  |
|  22 - 30 years | 0 / 14 | 0 / 21 | 0 / 0 | 0 / 35  |
|  31 - 40 years | 3 / 48 | 1 / 49 | 0 / 0 | 4 / 97  |
|  41 - 50 years | 5 / 43 | 4 / 38 | 0 / 0 | 9 / 81  |
|  51 - 60 years | 5 / 63 | 1 / 31 | 0 / 0 | 6 / 94  |
|  >60 years | 6 / 110 | 4 / 105 | 0 / 0 | 10 / 215  |
|  Unknown age | 0 / 14 | 0 / 4 | 0 / 19 | 0 / 37  |

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.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN/K081164](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN/K081164)

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