(287 days)
Not Found
No
The device is a laboratory kit for immunofluorescence staining and microscopic examination, with no mention of automated analysis or computational methods.
No
The device is described as a "Chlamydiae Culture Confirmation Kit" intended for the "qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence." This indicates a diagnostic purpose, not a therapeutic one. It identifies a condition but does not treat or prevent it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit "is intended for the qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence." This indicates that the device is used to detect a specific pathogen, which is a diagnostic purpose.
No
The device is a kit containing reagents, control slides, and fluids for a laboratory test. It requires a fluorescence microscope for examination, which is a hardware component. The description focuses on the chemical and biological components of the kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures". This is a diagnostic purpose, aiming to identify the presence of a specific pathogen.
- Device Description: The device is a "Kit" containing reagents and controls used to perform a test on biological samples (inoculated cell cultures derived from patient specimens). This is characteristic of an IVD.
- Methodology: The method used is immunofluorescence, which is a common technique in in vitro diagnostics for detecting antigens or antibodies.
- Performance Studies: The document describes clinical performance studies evaluating the device's ability to detect Chlamydiae in specimens, comparing it to other marketed "Culture Confirmation Kits". This type of evaluation is required for IVD devices to demonstrate their accuracy and reliability.
- Key Metrics: The document provides key performance metrics like Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), which are standard measures used to assess the performance of diagnostic tests.
- Predicate Devices: The mention of "Predicate Device(s)" with K numbers indicates that this device is being compared to previously cleared IVD devices, a process common in regulatory submissions for new IVDs.
All of these factors strongly indicate that the Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit is intended for the qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Performance has not been established with direct patient specimens.
Product codes (comma separated list FDA assigned to the subject device)
LJP
Device Description
The Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit includes a Chlamydiae DFA Reagent that contains a blend of two murine MAbs directed against epitopes on the lipopolysaccharide of Chlamydiae. The kit is used for Chlamydiae detection in cell cultures of patient specimens.
Kit Components:
Chlamydiae DFA Reagent - one dropper bottle containing fluorescein labeled murine MAbs directed against Chlamydiae. The buffered, stabilized, aqueous solution contains Evan's Blue as a counter-stain and 0.1% sodium azide as preservative.
Chlamydiae Antigen Control Slides - 10 slides. Five individually packaged control slides with wells containing cell culture-derived Chlamydia trachomatis positive cells and five individually packaged control slides with wells containing cell culture-derived negative cells. Each slide is intended to be stained only one time.
PBS Concentrate - a 40X concentrate consisting of 4% sodium azide (after dilution to 1X in water, the concentration of sodium azide in the solution is 0.1%) in PBS
Mounting Fluid - an aqueous, buffered, stabilized solution of glycerol and 0.1% sodium azide.
The cell cultures to be tested are fixed in acetone. The Chlamydiae DFA Reagent is added to the cells to determine the presence of chlamydial antigens (LPS). After incubating at 35°C to 37°C, the stained cells are rinsed with the diluted PBS Concentrate, a drop of the supplied Mounting Fluid is added and the monolayer is examined for presence of fluorescent inclusions using a fluorescence microscope equipped with the correct filter combination for FITC at a magnification of 100-400X.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluorescence microscope
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical Performance: The D3 DFA Chlamydiae Culture Confirmation Kit was characterized for its ability to specifically detect Chlamydiae species. The FITC-conjugated MAbs used in the kit exhibited characteristic staining patterns on Chlamydiae infected cells, with fluorescent inclusions in infected cells. The conjugated MAbs reacted with Chlamydophila pneumoniae, Chlamydophila psittaci, as well as 15 serovars of Chlamydia trachomatis.
The D DFA Chlamydiae Culture Confirmation Kit was tested for cross-reactivity against a wide variety of cells and microorganisms. No cross-reactivity was observed for 20 host culture cell types or for 57 virus strains (cultured and processed for staining). Twenty-five (25) bacterial cultures, as well as one protozoan and one yeast specimen, were stained and examined for cross-reactivity. The protein-A produced by Staphylococcus aureus bound the Fc portion of the MAb's and appeared as small points of fluorescence while all other bacterial cultures were negative.
To test this product against Chlamydiae species, cell cultures (McCoy, BGMK, or HEp-2) were inoculated with approximately 1.5 x 10^6 infective units of Chlamydia trachomatis, Chlamydophila psittaci, or Chlamydophila pneumoniae, and incubated for 2 days to yield a 3+ to 4+ infection. Cultures were processed and stained with the Chlamydia DFA Reagent or specially prepared DFA reagents containing only one of the Chlamydia MAbs.
Stringent conditions for cross-reactivity testing were achieved by using a high concentration Chlamydiae DFA Reagent and high titers of microorganisms. The DFA was prepared at 1.5X the concentration that is provided in the kit.
Depending on the particular bacteria, the number of CFU tested ranged from 6.4x10^4 to 2.9x10^7. Depending on the virus, 150 to 2100 TCID50 viruses 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 1.5X DFA according to the procedure detailed in the product insert. Additionally, for some viruses and other microorganisms, commercial slides containing the particular agent were used to test for cross reactivity.
Cell cultures were prepared in shell vial format. Confluent monolayers were stained with the 1.5X DFA Reagent according to the procedure as detailed in this product insert, then examined for cross reactivity.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance: Clinical studies included nine hundred and ninety four (994) original specimens evaluated for the presence of Chlamydiae by this product ("Subject" test) and three currently marketed Culture Confirmation Kits ("Comparison" tests). These evaluations were conducted at three external laboratory sites using one Comparison Device (American Microscan DFA Chlamydia Detection Kit) and one in-house laboratory where the two other Comparison Devices were used: (1) A reference laboratory in the southeastern United States; (2) A hospital laboratory in the mid-west United States; (3) A hospital laboratory in the southwestern United States; and (4) Diagnostic Hybrids' in-house virology laboratory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA): 95.5% (95% CI: 84.5%-99.4%)
Negative Percent Agreement (NPA): 99.4% (95% CI: 98.3%-99.8%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3120 Chlamydia serological reagents.
(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).
0
DIAGNOSTIC HYBRIDS, INC 350 West State Street Athens, OHIO 45701
Image /page/0/Picture/1 description: The image shows a logo for Diagnostic Hybrids, with the tagline "Integrating Science and Humanity." To the right of the text is an image of a person with their arms raised above their head, and the person is superimposed on a DNA strand. Below the logo is the number K063675 in a handwritten style.
510(k) SUMMARY
D3 HERPES SIMPLEX VIRUS IDENTIFICATION KIT
SEP 2 4 2007
| Applicant | DIAGNOSTIC HYBRIDS, INC.
350 West State Street
Athens, OHIO 45701 | | |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--|
| Contact Information | Gail R. Goodrum
Vice President, Regulatory and Quality Affairs
E-mail: goodrum@dhiusa.com
Telephone: 740.593.1784
Desk Extension: 740.593.1787
FAX: 740.597.1546 | | |
| Date of preparation of
510(k) summary: | September 21, 2007 (revised) | | |
| Device Name | Trade name - Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit
Common name - Fluorescent antibody test for Chlamydiae
Classification name Antiserum, fluorescent, Chlamydia trachomatis (21 CFR 866.3120,
product code LJP) | | |
| Legally marketed devices
to which equivalence is
claimed: | K864389 | American Microscan (distributed by Trinity Biotech) DFA Chlamydia
Detection Kit | |
| | K864663 | Kallestad (distributed by BioRad) Pathfinder® Chlamydia Culture
Confirmation Kit/System | |
| | K895839 | Diagnostic Products, Corp. (distributed by Remel) PathoDx® Chlamydia
Culture Confirmation Kit | |
| Device Description | The Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit includes a
Chlamydiae DFA Reagent that contains a blend of two murine MAbs directed against
epitopes on the lipopolysaccharide of Chlamydiae. The kit is used for Chlamydiae
detection in cell cultures of patient specimens.
Kit Components:
Chlamydiae DFA Reagent - one dropper bottle containing fluorescein labeled
murine MAbs directed against Chlamydiae. The buffered, stabilized, aqueous solution
contains Evan's Blue as a counter-stain and 0.1% sodium azide as preservative.
Chlamydiae Antigen Control Slides - 10 slides. Five individually packaged
control slides with wells containing cell culture-derived Chlamydia trachomatis positive
cells and five individually packaged control slides with wells containing cell culture-
derived negative cells. Each slide is intended to be stained only one time.
PBS Concentrate - a 40X concentrate consisting of 4% sodium azide (after
dilution to 1X in water, the concentration of sodium azide in the solution is 0.1%) in PBS
Mounting Fluid - an aqueous, buffered, stabilized solution of glycerol and 0.1%
sodium azide.
The cell cultures to be tested are fixed in acetone. The Chlamydiae DFA Reagent
is added to the cells to determine the presence of chlamydial antigens (LPS). After
incubating at 35°C to 37°C, the stained cells are rinsed with the diluted PBS
Concentrate, a drop of the supplied Mounting Fluid is added and the monolayer is
examined for presence of fluorescent inclusions using a fluorescence microscope | | |
Section 5-1 of 5-6
equipped with the correct filter combination for FITC at a magnification of 100-400X.
1
Image /page/1/Picture/0 description: The image shows the words "DIAGNOSTIC" on top of the word "HYBRIDS". The words are in a bold, sans-serif font. The words are stacked on top of each other, with "DIAGNOSTIC" being slightly smaller than "HYBRIDS".
Chlamydiae infected cells will be stained with bright apple-green fluorescence while uninfected cells will contain no apple-green fluorescence but will fluoresce red by the Evan's Blue counter-stain which is included in the Chlamydiae DFA Reagent. If no fluorescent cells are found, report result as, "No Chlamydiae detected". If fluorescent cells are found, indicating a Chlamydiae-positive specimen, report result as, "Chlamydiae isolated by cell culture." Included in the kit are Chlamydiae Antigen Control Slides. A Control Slide is intended to function as an indicator that the kit reagents are working properly in the test. (The slides are prepared with either Chlamydiae infected cells (Positive Antigen Control Slide) or uninfected cells (Negative Antigen Control Slide).1 Positive and negative controls must demonstrate appropriate staining characteristics for specimen results to be valid. Controls may also aid in the interpretation of test results. It is recommended that cell culture positive (infected with known Chlamydiae isolate) and negative (uninfected cells) controls be run with each assay to provide a means to ensure adequate performance of the cell culture system used. If control cultures fail to perform correctly, results are considered invalid. Intended Use The Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit is intended for the qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Performance has not been established with direct patient specimens. Explanation The test kit uses Chlamydiae antigen-specific murine MAbs that are directly labeled with fluorescein for rapid detection and identification of Chlamydiae. The cell cultures to be tested are fixed in acetone. The Chlamydiae DFA Reagent is added to the cells to determine the presence of chlamydial antigens. After incubating at 35℃ to 37℃, the stained cells are rinsed with the diluted PBS Concentrate, a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. Technological Fundamental technology and intended use of the device are similar as those of the Characteristics predicate devices, which are based on a standard immunofluorescence assay technique using cells inoculated with patient specimens. They employ directly labeled fluorescein monoclonal antibodies specific for Chlamydiae antigens enabling visualization of the
infected cells. A summary is provided in the table below:
Direct
Specimens
No
No
No
No
Non-clinical Performance
Staining patterns of the conjugated monoclonal antibodies on Chlamydiae infected cells were similar to those of the predicate devices.
Culture
Confirmation
Yes
Yes
Yes
Yes
FITC
Label
Yes
Yes
Yes
Yes
Monoclonal
Antibody
Yes
Yes
Yes
Yes
The D3 DFA Chlamydiae Culture Confirmation Kit was characterized for its ability
510(k) summary
Target antigen
(epitopes of the Chlamydiae lipopolysaccharide)
Yes
Yes
Yes
Yes
Athens, Ohio 45701 •
Chlamydiae
Test Systems
Diagnostic
Microscan Kallestad
Diagnostic
Products,
Corp.
Hybrids American DFA
Yes
Yes
Yes
Yes
2
to specifically detect Chlamydiae species. The FITC-conjugated MAbs used in the kit exhibited characteristic staining patterns on Chlamvdiae infected cells, with fluorescent inclusions in infected cells. The conjugated MAbs reacted with Chlamydophila pneumoniae, Chlamydophila psittaci, as well as 15 serovars of Chlamydia trachomatis.
The D DFA Chlamydiae Culture Confirmation Kit was tested for cross-reactivity against a wide variety of cells and microorganisms. No cross-reactivity was observed for 20 host culture cell types or for 57 virus strains (cultured and processed for staining). Twenty-five (25) bacterial cultures, as well as one protozoan and one yeast specimen, were stained and examined for cross-reactivity. The protein-A produced by Staphylococcus aureus bound the Fc portion of the MAb's and appeared as small points of fluorescence while all other bacterial cultures were negative.
To test this product aqainst Chlamydiae species, cell cultures (McCov, BGMK, or HEp-2) were inoculated with approximately 1.5 x 106 infective units of Chlamydia trachomatis, Chlamydophila psittaci, or Chlamydophila pneumoniae, and incubated for 2 days to vield a 3+ to 4+ infection. Cultures were processed and stained with the Chlamydia DFA Reagent or specially prepared DFA reagents containing only one of the Chlamydia MAbs.
Stringent conditions for cross-reactivity testing were achieved by using a high concentration Chlamydiae DFA Reagent and high titers of microorganisms. The DFA was prepared at 1.5X the concentration that is provided in the kit.
Depending on the particular bacteria, the number of CFU tested ranged from 6.4x10 to 2.9x10'. Depending on the virus, 150 to 2100 TCID50 viruses were inoculated into shell vial culture and incubated for 24 to 48 hours, to vield a 1+ to 3+ infection, processed and stained with the 1.5X DFA according to the procedure detailed in the product insert. Additionally, for some viruses and other microorganisms, commercial slides containing the particular agent were used to test for cross reactivity.
Cell cultures were prepared in shell vial format. Confluent monolayers were stained with the 1.5X DFA Reagent according to the procedure as detailed in this product insert, then examined for cross reactivity.
Organisms and cell lines which were tested against the Chlamydiae DFA Reagent are listed below.
| MICROORGANISMS (BACTERIA, YEAST, PROTOZOA) | |||
|---|---|---|---|
| CHLAMYDIAE | Serovar | Inoculum (Infective | |
| units per culture) | Result | ||
| (Reactive = +) | |||
| (Negative = -) | |||
| Chlamydia | |||
| trachomatis | A | 1.5 x 106 | + |
| B | 1.5 x 106 | + | |
| C | 1.5 x 106 | + | |
| D | 1.5 x 106 | + | |
| E | 1.5 x 106 | + | |
| F | 1.5 x 106 | + | |
| G | 1.5 x 106 | + | |
| H | 1.5 x 106 | + | |
| I | 1.5 x 106 | + | |
| J | 1.5 x 106 | + | |
| K | 1.5 x 106 | + | |
| L1 | 1.5 x 106 | + | |
| L2 | 1.5 x 106 | + | |
| L3 | 1.5 x 106 | + | |
| Chlamydophila pneumoniae | Ba | 1.5 x 106 | + |
| Chlamydophila psittaci | Chlamydophila pneumoniae | 1.5 x 106 | + |
Results of Specificity and Cross Reactivity Testing
510(k) summary
Page 5-3 of 5-6
3
| | OTHER BACTERIA | CFU Tested | Result
(Reactive = +)
(Negative = -) |
|-------------------|-------------------------------|---------------------------------------|--------------------------------------------|
| | Acholeplasma laidlawi | ~1.0 x 107 | - |
| | Acinetobacter calcoaceticus | 9.7 x 105 | - |
| | Bordetella bronchiseptica | 1.8 x 105 | - |
| | Bordetella pertussis | 4.7 x 106 | - |
| | Corynebacterium diphtheriae | 2.5 x 106 | - |
| | Escherichia coli | 2.6 x 105 | - |
| | Gardnerella vaginalis | 5.0 x 105 | - |
| | Haemophilis influenzae type A | 9.3 x 105 | - |
| | Klebsiella pneumoniae | 6.4 x 106 | - |
| | Legionella pneumophila | 6.5 x 104 | - |
| | Moraxella cartarrhalis | 6.4 x 104 | - |
| | Mycoplasma hominis | ~1.0 x 104 | - |
| | Mycoplasma orale | ~1.0 x 104 | - |
| | Mycoplasma pneumoniae | ~1.0 x 104 | - |
| | Mycoplasma salivarium | ~1.0 x 107 | - |
| | Neisseria gonorrhoeae | 1.3 x 106 | - |
| | Proteus mirabilis | 2.1 x 106 | - |
| | Pseudomonas aeruginosa | 1.0 x 103 | - |
| | Salmonella enteriditis | 2.5 x 106 | - |
| | Salmonella typhimurium | 1.8 x 106 | - |
| | Staphylococcus aureus | 1.0 x 107 | + |
| | Streptococcus agalactiae | 9.6 x 105 | - |
| | Streptococcus pneumoniae | 8.0 x 105 | - |
| | Streptococcus pyogenes | 2.9 x 107 | - |
| | Ureaplasma urealyticum | ~1.0 x 104 | - |
| | | | Result
(Reactive = +)
(Negative = -) |
| | YEAST | CFU Tested | (Reactive = +)
(Negative = -) |
| | Candida glabrata | 8.7 x 106 | - |
| | PROTOZOAN | CFU Tested | Result
(Reactive = +)
(Negative = -) |
| | Trichomonas vaginalis | Commercially available control slidea | - |
| VIRUS STRAINS | | Inoculum (TCID50) | Result
(Reactive = +)
(Negative = -) |
| | Type 1 | 725 | - |
| | Type 3 | 725 | - |
| | Type 6 | 725 | - |
| | Type 7 | 725 | - |
| | Type 8 | 725 | - |
| Adenovirus | Type 10 | 725 | - |
| | Type 13 | 725 | - |
| | Type 14 | 725 | - |
| | Type 18 | 725 | - |
| | Type 31 | 725 | - |
| | Type 40 | 725 | - |
| | Type 41 | 725 | - |
| Influenza A | Aichi | 2.1 x 103 | - |
| | Malaya | 2.1 x 103 | - |
| | | | |
| | Hong Kong | $2.1 \times 10^3$ | - |
| | Denver | $2.1 \times 10^3$ | - |
| | Port Chalmers | $2.1 \times 10^3$ | - |
| | PR | $2.1 \times 10^3$ | - |
| | Victoria | $2.1 \times 10^3$ | - |
| | Hong Kong | $2.1 \times 10^3$ | - |
| | Maryland | $2.1 \times 10^3$ | - |
| Influenza B | Mass | $2.1 \times 10^3$ | - |
| | Taiwan | $2.1 \times 10^3$ | - |
| | GL | $2.1 \times 10^3$ | - |
| | Russia | $2.1 \times 10^3$ | - |
| | Long | $2.1 \times 10^3$ | - |
| RSV | Wash | $2.1 \times 10^3$ | - |
| | 9320 | $2.1 \times 10^3$ | - |
| Parainfluenza 1 | C-35 | Commercially available control slidea | - |
| Parainfluenza 2 | Greer | Commercially available control slidea | - |
| Parainfluenza 3 | C 243 | Commercially available control slidea | - |
| HSV-1 | 1F | 150 | - |
| | MacIntyre | 150 | - |
| HSV-2 | MS | 150 | - |
| | Strain G | 150 | - |
| CMV | Towne | 700 | - |
| | AD169 | 700 | - |
| | Davis | 700 | - |
| VZV | Ellen | 500 | - |
| Echovirus | 4, 6, 9, 11, 30, 34 | Commercially available control slidea | - |
| Coxsackievirus | B1, B2, B3, B4, B5, B6 | Commercially available control slidea | - |
| Mumps | | Commercially available control slidea | - |
| Measles (Rubeola) | | Commercially available control slidea | - |
| Poliovirus | Types 1, 2, 3 | Commercially available control slidea | - |
| Epstein-Barr | | Commercially available control slidea | - |
8 Test material is from commercially available prepared slides. Each positive well contains 10 to 50% reactive cells. :
510(k) summary
350 West Street ▪ ▪ Athens, Ohio 45701 ▪ ▪ 1-800-344-5847 ▪ ▪ Fax 740-593-0980 ▪ www.dhiusa.com
4
Clinical Performance
Clinical studies included nine hundred and ninety four (994) original specimens evaluated for the presence of Chlamydiae by this product ("Subject" test) and three currently marketed Culture Confirmation Kits ("Comparison" tests). These evaluations were conducted at three external laboratory sites using one Comparison Device (American Microscan DFA Chlamydia Detection Kit) and one in-house laboratory where the two other Comparison Devices were used: (1) A reference laboratory in the southeastern United States; (2) A hospital laboratory in the mid-west United States; (3) A hospital laboratory in the southwestern United States; and (4) Diagnostic Hybrids' inhouse virology laboratory.
A summary of the specimens by Site is presented in the table below.
| | Fresh
prospective | Frozen
prospective | Archived
(frozen) | Site Total |
|---|----------------------|-----------------------|----------------------|------------|
| 1 | 156 | 240 | 0 | 396 |
| 2 | 90 | 84 | 26 | 200 |
| 3 | 23 | 68 | 187 | 278 |
| 4 | 0 | 120 | 0 | 120 |
510(k) summary
Page 5-5 of 5-6
350 West State Street
Athens, Ohio 45701
350 West State Street ▪ ● Athens, Ohío 45701 ▪ ▪ 1-800-344-5847 ▪ ▪ Fax 740-593-0980 ▪ www.chiusa.com
5
Percent Agreement and 95% Confidence Interval between the Subject Device and Comparison test for the three external laboratory sites was calculated and is presented in the table below (results from both fresh and frozen specimens are included). Percent Agreement of All Tests
| Comparison Device | |||
|---|---|---|---|
| + | - | ||
| Subject Device Diagnostic | |||
| Hybrids | + | 42 | 4 |
| - | 2 | 613 | |
| Positive Percent Agreementb (PPA) | 95.5% | ||
| 95% CIc- PPA | 84.5%-99.4% | ||
| Negative Percent Agreementd (NPA) | 99.4% | ||
| 95% CI - NPA | 98.3%-99.8% |
Specter, S., Hodinka, R. L., and Young, S.A. 2000, Clinical Virology Manual, Washington D.C., ASM Press, 420-424.
350 West State Street
® "Positive Percent Agreement", or "PPA", values were calculated according to {[Total Number of Positive Results in Agreement by both Subject and Comparison Tests) divided by ((Total Number of Positive Results in Agreement by both Subject and Comparison Tests) plus (Number of Results Positive by Comparison but Negative by Subject)}} multiplied by 100%. " "95% Cl" refers to 95% Confidence Intervals, which were calculated according to Exact method (Clopper, C. and S. Pearson, Biometrika 26:404-413, 1934).
d "Negative Percent Agreement", or "NPA", values were calculated according to {[Total Number of Negative Results in Agreement by both Subject and Comparison Tests) divided by [(Total Number of Negative Results in Agreement by both Subject and Comparison Tests) plus (Number of Results Negative by Comparison but Positive by Subject)]} multiplied by 100%.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES. USA
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Gail R. Goodrum Vice President, Regulatory and Quality Affairs Diagnostic Hybrids, Inc. 350 West State Street Athens, OH 45701
SEP 2 4 2007
Re: K063675 Trade/Device Name: Diagnostic Hybrids' D' Chlamydiae Culture Confirmation Kit Regulation Number: 21 CFR § 866.3120 Regulation Name: Chlamydia serological reagents Regulatory Class: I Product Code: LJP Dated: August 10, 2007 Received: August 13, 2007
Dear Ms. Goodrum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
7
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitto Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attayna
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K063675
Device Name: Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit
Indications for Use: The Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit is intended for the qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Performance has not been established with direct patient specimens.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use __
(21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
the Schif
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 063675