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.

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. 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.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for the D3 DFA Chlamydiae Culture Confirmation Kit:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Specificity (No Cross-Reactivity): The device should not react with common host cells and a wide variety of microorganisms (viruses, bacteria, yeast, protozoa).	Met: - No cross-reactivity observed for 20 host culture cell types. - No cross-reactivity observed for 57 virus strains. - No cross-reactivity observed for 24 of 25 bacterial cultures tested (Staphylococcus aureus showed small points of fluorescence due to protein-A binding to MAb Fc portion, but not a positive Chlamydiae reaction). - No cross-reactivity with one protozoan (Trichomonas vaginalis) and one yeast (Candida glabrata).
Detection of Chlamydiae Species: The device must specifically detect various Chlamydiae species and serovars.	Met: - Reacted positively with Chlamydophila pneumoniae, Chlamydophila psittaci, and 15 serovars of Chlamydia trachomatis (A, B, C, D, E, F, G, H, I, J, K, L1, L2, L3).
Overall Agreement with Comparison Device: The device's results should show high agreement with existing legally marketed comparison tests for Chlamydiae culture confirmation.	Met: - Positive Percent Agreement (PPA): 95.5% (95% CI: 84.5%-99.4%) - Negative Percent Agreement (NPA): 99.4% (95% CI: 98.3%-99.8%) (Note: The exact target for PPA and NPA as a formal "acceptance criterion" is not explicitly stated, but these high percentages demonstrate good performance relative to predicate devices.)
Characteristic Staining Patterns: The FITC-conjugated MAbs should exhibit characteristic staining patterns on Chlamydiae infected cells.	Met: - The FITC-conjugated MAbs exhibited characteristic staining patterns on Chlamydiae infected cells, with fluorescent inclusions in infected cells. - Chlamydiae infected cells stained with bright apple-green fluorescence, while uninfected cells contained no apple-green fluorescence.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Clinical Performance Test Set: 994 original specimens.
  - Provenance: Collected from three external laboratory sites and Diagnostic Hybrids' in-house laboratory in the United States.
    - Site 1: A reference laboratory in the southeastern US (396 specimens – 156 fresh prospective, 240 frozen prospective).
    - Site 2: A hospital laboratory in the mid-west US (200 specimens – 90 fresh prospective, 84 frozen prospective, 26 archived frozen).
    - Site 3: A hospital laboratory in the southwestern US (278 specimens – 23 fresh prospective, 68 frozen prospective, 187 archived frozen).
    - Site 4: Diagnostic Hybrids' in-house virology laboratory (120 specimens – 120 frozen prospective).
  - Nature: A mix of fresh prospective, frozen prospective, and archived (frozen) specimens.
- Non-Clinical Performance (Specificity/Cross-Reactivity/Detection Test Set):
  - 20 host culture cell types.
  - 57 virus strains.
  - 25 bacterial cultures.
  - 1 protozoan (Trichomonas vaginalis).
  - 1 yeast (Candida glabrata).
  - Chlamydophila pneumoniae, Chlamydophila psittaci, and 15 serovars of Chlamydia trachomatis.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document describes comparison to "three currently marketed Culture Confirmation Kits ('Comparison' tests)" at various laboratory sites. It does not explicitly state the number or qualifications of human experts who established the ground truth for the clinical samples. The "ground truth" for the clinical study appears to be the results obtained from these predicate devices.
- For the non-clinical specificity/reactivity testing, "cells were examined for cross reactivity" and "stained cells are rinsed... and the monolayer is examined for presence of fluorescent inclusions using a fluorescence microscope." This implies human observation, but no specific number or qualifications of experts are given.
Adjudication Method for the Test Set:
- Not specified. The clinical performance section directly compares the "Subject Device" to "Comparison Devices" to calculate percent agreement. There is no mention of an adjudication process if the results differed between the subject device and the comparison test.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The device is a diagnostic kit (reagents and controls) for laboratory use, not an AI-assisted diagnostic tool for image interpretation by human readers.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The performance data presented (Positive Percent Agreement, Negative Percent Agreement, Specificity, Detection) reflect the performance of the "Subject Device" (the D3 DFA Chlamydiae Culture Confirmation Kit) as a standalone diagnostic assay. While human observation through a fluorescence microscope is part of the kit's intended use for result interpretation, the performance statistics are attributed directly to the kit's diagnostic capability in identifying the Chlamydiae LPS antigens. The "algorithm" here refers to the immunofluorescence assay itself, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For clinical performance, the ground truth was established by results from "three currently marketed Culture Confirmation Kits ('Comparison' tests)," which are themselves established diagnostic methods. This can be considered a form of comparison to predicate device results.
- For non-clinical performance (specificity and reactivity), the ground truth was based on the known presence or absence of specific Chlamydiae species, other microorganisms, and host cell types in the prepared cultures, often at a "3+ to 4+ infection" level for positive controls. This relies on known culture characteristics/identification (e.g., specific Chlamydia trachomatis serovars, identified bacterial or viral strains).
The Sample Size for the Training Set:
- The document does not explicitly delineate a "training set" in the context of a machine learning algorithm. This device is a diagnostic reagent kit, not an AI system. The development and validation of such a kit would involve internal research and development using various samples to formulate and refine the reagents, but this is not typically referred to as a "training set" in the same way as for AI. The detailed data presented are for the validation or test sets.
How the Ground Truth for the Training Set Was Established:
- As stated above, the concept of a "training set" with established ground truth as used in AI/machine learning does not directly apply to this type of diagnostic kit. The formulation and initial testing of the antibodies and reagents would be based on known laboratory strains and isolates, confirmed through established microbiological techniques.

Summary

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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 StreetAthens, OHIO 45701
Contact Information	Gail R. GoodrumVice President, Regulatory and Quality AffairsE-mail: goodrum@dhiusa.comTelephone: 740.593.1784Desk Extension: 740.593.1787FAX: 740.597.1546
Date of preparation of510(k) summary:	September 21, 2007 (revised)
Device Name	Trade name - Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation KitCommon name - Fluorescent antibody test for ChlamydiaeClassification name Antiserum, fluorescent, Chlamydia trachomatis (21 CFR 866.3120,product code LJP)
Legally marketed devicesto which equivalence isclaimed:	K864389	American Microscan (distributed by Trinity Biotech) DFA ChlamydiaDetection Kit
	K864663	Kallestad (distributed by BioRad) Pathfinder® Chlamydia CultureConfirmation Kit/System
	K895839	Diagnostic Products, Corp. (distributed by Remel) PathoDx® ChlamydiaCulture Confirmation Kit
Device Description	The Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit includes aChlamydiae DFA Reagent that contains a blend of two murine MAbs directed againstepitopes on the lipopolysaccharide of Chlamydiae. The kit is used for Chlamydiaedetection in cell cultures of patient specimens.Kit Components:Chlamydiae DFA Reagent - one dropper bottle containing fluorescein labeledmurine MAbs directed against Chlamydiae. The buffered, stabilized, aqueous solutioncontains Evan's Blue as a counter-stain and 0.1% sodium azide as preservative.Chlamydiae Antigen Control Slides - 10 slides. Five individually packagedcontrol slides with wells containing cell culture-derived Chlamydia trachomatis positivecells 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 (afterdilution to 1X in water, the concentration of sodium azide in the solution is 0.1%) in PBSMounting 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 Reagentis added to the cells to determine the presence of chlamydial antigens (LPS). Afterincubating at 35°C to 37°C, the stained cells are rinsed with the diluted PBSConcentrate, a drop of the supplied Mounting Fluid is added and the monolayer isexamined 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.

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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

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

FITC

Label

Yes

Monoclonal

Antibody

Yes

The D3 DFA Chlamydiae Culture Confirmation Kit was characterized for its ability

510(k) summary

Target antigen

(epitopes of the Chlamydiae lipopolysaccharide)

Yes

Athens, Ohio 45701 •

Chlamydiae

Test Systems

Diagnostic

Microscan Kallestad

Diagnostic

Products,

Corp.

Hybrids American DFA

Yes

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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 (Infectiveunits per culture)	Result(Reactive = +)(Negative = -)
Chlamydiatrachomatis	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

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	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

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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.

	Freshprospective	Frozenprospective	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

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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 DiagnosticHybrids	+	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%.

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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).

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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

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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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Regulation Number and Section

§ 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).