ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS

K973707 · Roche Molecular Systems, Inc. · MKZ · Aug 4, 1999 · Microbiology

Device Facts

• Record ID: K973707
• Device Name: ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
• Applicant: Roche Molecular Systems, Inc.
• Product Code: MKZ · Microbiology
• Decision Date: Aug 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Intended Use

The AMPLICOR CT/NG Test for Chlamydia trachomatis is a qualitative in vitro test for the detection of Chlamydia trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens as evidence of symptomatic or asymptomatic infection with Chlamydia trachomatis. Chlamydia trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target and by hybridization capture of the amplified target.

Device Story

In vitro diagnostic test for Chlamydia trachomatis; utilizes PCR amplification of target plasmid DNA from urogenital specimens (urine, endocervical/urethral swabs). Includes internal control to identify PCR inhibitors. Principle of operation: PCR amplification followed by hybridization capture; detection via absorbance measurement of chromophore produced by oxidation of 3,3',5'-tetramethylbenzidine by hydrogen peroxide in presence of horseradish peroxidase. Used in clinical laboratories; operated by trained laboratory personnel. Output provided as qualitative result (positive/negative). Assists clinicians in diagnosing C. trachomatis infection; testing both swab and urine specimens may increase confidence in positive results.

Clinical Evidence

Clinical study at six sites with 8,521 specimens from 4,298 patients. Compared AMPLICOR results to composite culture/DFA reference. Excluded 143 equivocal and 69 inhibitory specimens. Sensitivity and specificity varied by specimen type and symptom status; overall female sensitivity 94.1% (95% CI: 91.6-96.6), specificity 98.4% (95% CI: 98.0-98.8); male sensitivity 92.9% (95% CI: 90.7-95.1), specificity 94.7% (95% CI: 93.9-95.5). Analytical sensitivity: 1 IFU/test for 15 serovars. Analytical specificity tested against 132 bacteria, 6 fungi, 1 protozoon, 11 viruses.

Technological Characteristics

Multiplex in vitro diagnostic test. Uses PCR amplification and hybridization capture. Detection via absorbance measurement (A450) of chromophore (3,3',5'-tetramethylbenzidine oxidation). Includes internal control for PCR inhibition. Designed for use with COBAS AMPLICOR Analyzer. Qualitative output.

Indications for Use

Indicated for qualitative detection of Chlamydia trachomatis plasmid DNA in male/female urine, female endocervical swabs, and male urethral swabs. Applicable to both symptomatic and asymptomatic patients.

Regulatory Classification

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 genus Chlamydia 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).

Reference Devices

• AMPLICOR Chlamydia trachomatis Test
• COBAS AMPLICOR Chlamydia trachomatis Test

Submission Summary (Full Text)

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510(k) Summary

AMPLICOR™ CT/NG Test for Chlamydia trachomatis

510(k) Summary

AMPLICOR™ CT/NG Test for Chlamydia trachomatis Roche Molecular Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-1760 [phone]

#### Intended Use:

The AMPLICOR CT/NG Test for Chlamydia trachomans is a qualitative in virro test for the detection of C. trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens, and in male urethral swab specimens as evidence of symptomatic infection with C. rachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target.

#### Description of the Device:

The AMPLICOR CT/NG Test for Chlamydia trachomatis is a multiplex in vitro diagnostic test for the detection of Chlamydia trachomatis in male and female urogenital specimens. The AMPLICOR CT/NG Test for Chlamydia trachomatis also has an Internal Control that identifies specimens that contain substances inhibitory to PCR.

#### Similarities and Differences to Predicate Device:

The AMPLICOR CT/NG Test for Chlamydia trachomatis is substantially equivalent to other commercially available in viro diagnostic devices for the detection of Chlamydia trachomatis in urogenital swab and urine specimens. These methods include culture with immunofluorescent staining, ELISA, DFA, and nucleic acid hybridization. A commonality among all of these devices is that the unique biochemical properties of the target organism are all encoded in the DNA of the organism, essentially reducing each device to a test for genetic (i.e., phenotypic or genotypic) characteristics of the organism. The AMPLICOR CT.NG Test for Chlamydia trachomatis detects DNA from the cryptic plasmid of the Chlamydia trachomatis organism while cell culture detects the complete viable inclusion forming unit. The clinical performance of the AMPLICOR Chlamydia trachomatis Test has been shown to be substantially equivalent to cell culture methods.

The AMPLICOR CT/NG Test for Chlamydia trachomatis is also similar to the AMPLICOR Chlamydia trachomatis Test and to the COBAS AMPLICOR Chlamydia trachomatis Test performed on the COBAS AMPLICOR Analyzer. Improvements in the AMPLICOR CT/NG Test for Chlamydia trachomatis allow the automated multiplex amplification of Chlamydia trachomatis and an Internal Control that is used to detect the presence of PCR inhibitors. All of these tests use the same oligonucleotide primers and probe for the detection of Chlamydia trachomatis and have similar detections that are based on the absorbance measurement of a chromophore that is produced by the oxidation of 3,3',5'tetramethybenzidine by hydrogen peroxide in the presence of horseradish peroxidase.

### Non-Clinical Performance:

The AMPLICOR CT/NG Test for Chlamydia trachomatis was shown to have an analytical sensitivity (limit of detection) of 1 Inclusion Forming Unit (1 IFU) per test for all 15 Chlamydia serovars (A, B, Ba, C. D. E, F, G, H, I, J, K. LGV1, LGV2, LGV3).

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The analytical specificity of the AMPLICOR CT/NG Test for C. trachomatis was tested against 132 bacteria, 6 fungi, 1 protozoon and 11 virus isolates that mav be isolated from the urogenital tract. The AMPLICOR CTNG Test for C. trachomatis gave negative results for each isolate present in culture transport media and normal human urine at ≥ 104 copies of genomic DNA per test.

The precision of the AMPLICOR CT/NG Test for Chlamydia rachomatis was determined for a panel of CTM specimens containing 0, 1.25, 3.75 and 6.25 Chlamydia IFU/test and urine specimens containing 0, 1, 3 and 5 Chlamydia trachomatis IFU/test. Three independent operators at three different geographical sites tested the panel once a day for three days in duplicate. The AMPLICOR CT/NG Test for Chlamydia trachomatis gave 100% qualitatively correct and concordant results across all specimen types, concentrations and sites. The results of this study are presented in Tables 1 and 2.

| | <i>C. trachomatis</i> Spiked CTM (IFU/test) | | | |
|----------------------|---------------------------------------------|-------|-------|-------|
| | 0 | 1.25 | 3.75 | 6.25 |
| Number of Replicates | 72 | 36 | 36 | 36 |
| % Correct Results | 100 | 100 | 100 | 100 |
| Median A450 | 0.056 | 4.000 | 4.000 | 4.000 |
| Minimum A450 | 0.049 | 4.000 | 4.000 | 4.000 |
| Maximum A450 | 0.073 | 4.000 | 4.000 | 4.000 |

| <b>Table 1</b> |
|---------------------------------------------------------------------------------------|
| <b>AMPLICOR CT/NG Test for Chlamydia trachomatis</b><br><b>CTM Specimen Precision</b> |

| <b>Table 2</b> |
|------------------------------------------------------|
| <b>AMPLICOR CT/NG Test for Chlamydia trachomatis</b> |
| <b>Urine Specimen Precision</b> |

| | C. trachomatis Spiked Urine (IFU/test) | | | |
|----------------------|----------------------------------------|-------|-------|-------|
| | 0 | 1 | 3 | 5 |
| Number of Replicates | 72 | 36 | 36 | 36 |
| % Correct Results | 100 | 100 | 100 | 100 |
| Median A450 | 0.057 | 4.000 | 4.000 | 4.000 |
| Minimum A450 | 0.049 | 1.491 | 1.893 | 2.538 |
| Maximum A450 | 0.083 | 4.000 | 4.000 | 4.000 |

### Clinical Performance:

The AMPLICOR CT/NG Test for Chlamydia trachomatis was evaluated in a clinical study conducted at six geographically diverse sites. Swab (endocervical and urethral for females, urethral for males) and urine specimens were obtained from all patients entered into the study. Swab specimens were placed in culture transport media (CTM) used at each site. All swab specimens were tested by standard culture with cyclohexamide treated McCoy cells stained with fluorescein-labeled monoclonal antibody for C. trachomatis. Swab specimens that were culture negative by the AMPLICOR Test were tested by DFA for the presence of C. trachomatis. The AMPLICOR CT/NG Test for Chlamydia trachomatis was

f rey/regdocs/cing cimwp/fdaresp7-31/final 510ksum/2

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performed on all endocervical swab and urine specimens obtained from female patients, and all urethral swabs and urine specimens from male patients. AMPLICOR testing was repeated for all specimens with initial results in the range of 0.2 to 0.8 A350 and when IC results were inhibited (negative).

A total of 8521 specimens collected from 4298 patients met the inclusion in the clinical study (patient was not on antibiotics, a valid culture result was obtained, specimen met storage requirements etc.). Both a swab and urine specimen were entered into the study for 4206 patients: a urine specimen only was entered into the study from 101 patients. A swab specimen only was entered into the study from 36 patients. Of the 8521 specimens included in the study, 143 specimens gave initial test results in the Equivocal Range and were excluded from the data analyses. In addition, 69 specimens were repeatedly inhibitory and were excluded from the data analyses which include the use of the Internal because the results were not interpretable. Therefore, 8309 specimens were included in the analyses when the Internal Control result was used and a total of 8378 specimens were included in the analyses when the Internal Control results were not used.

The clinical performance of the test was evaluated by comparing the results of the 8378 swab and urine specimens to the composite results of the comparative tests (culture and DFA). Alternate PCR testing using oliognucleotide primers targeted for a region of the C. trachomatis MOMP gene was performed on AMPLICOR positive, culture/DFA negative specimens. The MOMP test results were not used to calculate the clinical performance characteristics of the test and are reported for information purposes only. Of the 242 AMPLICOR positive, culture/DFA negative specimens that were classified as false positive results in this study, 153 were positive for C. trachomatis when that specimen or the matching urine or swab specimen from that patient was tested by the MOMP assay. These data suggest that many specimens considered as false positive in the Clinical Data Performance Tables did contain C. trachomatis DNA.

The results from the clinical study are shown in Tables 3 and 4. Table 3 shows the clinical performance of the AMPLICOR CT/NG Test for Chlamydia trachomatis in comparison to the endocervical culture/DFA results for female patients and to the urethral culture/DFA results for male patients. In this Table, True Positive (TP) represents the number of concordant positive culture or DFA and AMPLICOR Test results. True Negative (TN) represents the number of concordant negative culture and AMPLICOR results. False Negative (FN) represents the number of culture positive, AMPLICOR negative results. False Positive (FP) represents the number of culture and DFA negative. AMPLICOR positive results.

Table 4 shows the clinical performance of the AMPLICOR CT/NG Test for Chlamydia trachomatis for testing both swab and urine specimens from female patients, combined and separately for each specimen type, in comparison to the patient infected status. Female patient infected status was determined by endocervical or urethral culture/DFA positive test results. The data in Table 4 show that there is better concordance with culture DFA positive patients when both swab and urine specimens are tested by the AMPLICOR CT/NG Test for Chlamydia trachomatis. The testing of both swab and urine specimens by the AMPLICOR CT/NG Test for Chlamydia trachomatis resulted in fewer unverified positive test results and higher assay sensitivity as compared to single specimen (swab or urine) testing only.

A summary of the test results obtained in the clinical study performed for the AMPLICOR CT/NG Test for Chlamydia trachomatis is contained in Tables 5 and 6. Table 5 summarizes the combinations of test results obtained for female patients; Table 6 summarizes the combinations of test results obtained for male patients. These tables show that patients with a positive result in both a urine and a swab specimen had a lower rate of unverified positives relative to culture and DFA) than single positive specimen results. Testing of both specimen types may be useful for increasing the confidence in a positive result using the AMPLICOR CT/NG Test for Chlamydia trachomatis, particularly for low prevalence populations.

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The clinical sensitivity and specificity of the AMPLICOR CT/NG Test for Chlamydia trachomatis has not been reliably determined for detecting those patients with clinically active infection that can be transmitted to partners or cause Chlamycia-related sequelae. In the clinical study described here, 23.1% of AMPLICOR positive results were from patients with negative cultures and DFA tests. The significance of AMPLICOR positive, but culture and DFA negative test results is unknown. A proportion of these AMPLICOR positive specimens (63.2%) were also positive by an alternate target PCR assay; however, the performance of this alternate target assay has not been established.

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| Sex | Specimen | Symptom | TP | TN | FP | FN | No. Inhib. | % Repeat. Inhibitory | Total | Sensitivity (95% CI) | Specificity (95% CI) | MOMP+/FP |
|--------|-------------------|--------------|--------|--------|-------|------|------------|----------------------|---------------------------|------------------------|------------------------|-----------|
| Female | CTM | Asymptomatic | 76 | 1019 | 14 | 4 | 0 | 0.00% | 1113 | 95.0%<br>(87.7-98.63) | 98.6%<br>(97.9-99.3) | 10/14 |
| | | (76) | (1019) | (14) | (4) | | | (1113) | (95.0%)<br>(87.7-98.63) | (98.6%)<br>(97.9-99.3) | (10/14) | |
| | CTM | Symptomatic | 94 | 1026 | 15 | 1 | 5 | 0.48% | 1141 | 98.9%<br>(94.3-100.0) | 98.6%<br>(97.8-99.3) | 10/15 |
| | | (94) | (1031) | (15) | (1) | | | (1141) | (98.9%)<br>(94.3-100.0) | (98.6%)<br>(97.8-99.3) | (10/15) | |
| Female | URINE | Asymptomatic | 68 | 1004 | 14 | 8 | 15 | 1.46% | 1109 | 89.5%<br>(82.6-96.4) | 98.6%<br>(97.9-99.3) | 10/14 |
| | | (67) | (1018) | (14) | (10) | | | (1109) | (87.0%)<br>(79.5-94.5) | (98.6%)<br>(97.9-99.3) | (10/14) | |
| | URINE | Symptomatic | 82 | 1021 | 24 | 7 | 10 | 0.96% | 1144 | 92.1%<br>(86.5-97.7) | 97.7%<br>(96.8-98.6) | 14/24 |
| | | (82) | (1032) | (23) | (7) | | | (1144) | (92.1%)<br>(86.5-97.7) | (97.8%)<br>(96.9-98.7) | (13/23) | |
| Female | Total for Females | | 320 | 4070 | 67 | 20 | 30 | 0.73% | 4507 | 94.1%<br>(91.6-96.6) | 98.4%<br>(98.0-98.8) | 44//67 |
| Female | Total for Females | | (319) | (4100) | (66) | (22) | | | (4507) | (93.5%)<br>(90.9-96.2) | (98.4%)<br>(98.0-98.8) | (43/66) |
| Male | CTM | Asymptomatic | 75 | 598 | 14 | 1 | 6 | 0.99% | 694 | 98.7%<br>(92.9-100.0) | 97.7%<br>(96.5-98.9) | 4/14 |
| | | (75) | (604) | (14) | (1) | | | (694) | (98.7%)<br>(92.9-1-100.0) | (97.7%)<br>(96.6-98.9) | (4/14) | |
| | CTM | Symptomatic | 181 | 974 | 49 | 7 | 12 | 1.21% | 1223 | 96.3%<br>(93.6-99.0) | 95.2%<br>(93.9-96.5) | 31/49 |
| | | (180) | (986) | (49) | (8) | | | (1223) | (95.7%)<br>(92.9-98.6) | (95.3%)<br>(94.0-96.6) | (31/49) | |
| Male | URINE | Asymptomatic | 69 | 603 | 27 | 6 | 0 | 0.00% | 705 | 92.0%<br>(85.9-98.1) | 95.7%<br>(94.1-97.3) | 14/27 |
| | | (69) | (603) | (27) | (6) | | | (705) | (92.0%)<br>(85.9-98.1) | (95.7%)<br>(94.1-97.3) | (14/27) | |
| | URINE | Symptomatic | 162 | 958 | 85 | 23 | 21 | 2.10% | 1249 | 87.6%<br>(82.8-92.3) | 91.9%<br>(90.2-93.5) | 60/85 |
| | | (160) | (981) | (83) | (25) | | | (1249) | (86.5%)<br>(81.6-91.4) | (92.2%)<br>(90.6-93.8) | (58/83) | |
| Male | Total for Males | | 487 | 3133 | 175 | 37 | 39 | 1.22% | 3871 | 92.9%<br>(90.7-95.1) | 94.7%<br>(93.9-95.5) | 109/175 |
| Male | Total for Males | | (484) | (3174) | (173) | (40) | | | (3871) | (92.4%)<br>(90.1-94.6) | (94.8%)<br>(94.1-95.6) | (107/173) |

Table 3 Clinical Performance Of AMPLICOR CT/NG Test for Chlamydia trachomatis Including and Excluding the Internal Control'

/ Test results without the Internal Control shown in parentheses.

True Positive (TP) represents the number of concordant positive culture or DFA and COBAS Test results. True Negative (TN) represents the number of concordant negative culture and COBAS results. False Negative (FN) represents the number of culture positive, COBAS negative results. False Positive (FP) represents the number of culture and DFA negative. COBAS positive results.

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| Sex | Specimen | Symptom | Total | %<br>Inhibitory | No.<br>Inhib. | Sensitivity<br>(95% CI) | Specificity<br>(95% CI) | MOMP+/FP |
|--------|-------------|-------------|----------------|-----------------|---------------|-------------------------|-------------------------|----------------------|
| Female | CTM + URINE | Asymp | 1123<br>(1121) | 0.00% | 0 | 93.1%<br>(88.8-98.4) | 98.0%<br>(97.1-98.8) | 16/21<br>(16/21) |
| | | Symptomatic | 1172<br>(1170) | 0.19% | 2 | 94.3%<br>(89.9-98.7) | 97.7%<br>(96.7-98.6) | 14/25<br>(14/25) |
| | CTM | Asymp | 1113<br>(1113) | 0.00% | 0 | 87.4%<br>(80.4-94.3) | 98.6%<br>(97.9-99.3) | 11/14<br>(11/14) |
| | | Symptomatic | 1141<br>(1141) | 0.48% | 5 | 94.0%<br>(89.3-98.7) | 98.6%<br>(97.8-99.3) | 11/15<br>(11/15) |
| | Total CTM | | 2254<br>(2254) | 0.24% | 5 | 90.9%<br>(86.8-95.0) | 98.6%<br>(98.1-99.1) | 22/29<br>(22/29) |
| | URINE | Asymp | 1109<br>(1109) | 1.46% | 15 | 84.3%<br>(76.5-92.2) | 98.8%<br>(98.1-99.5) | 10/12<br>(10/12) |
| | | Symptomatic | 1144<br>(1144) | 0.96% | 10 | 89.5%<br>(83.3-95.6) | 98.0%<br>(97.1-98.8) | 14/21<br>(14/21) |
| | | Total Urine | | 2253<br>(2253) | 1.21 | 25 | 87.1%<br>(82.2-92.0) | 98.4%<br>(97.8-98.9) |

## Table 4 Performance of AMPLICOR CT/NG Test for Chiamydia trachomatis vs Female Patient Status Including and Excluding the Internal Control'

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| No.<br>Patients | Culture<br>Status | Endocervical And Urethral Culture<br>Results | | | DFA<br>Results | AMPLICOR<br>Results by<br>Specimen Type | |
|-----------------|-------------------|----------------------------------------------|------------------|------------------|----------------|-----------------------------------------|-------|
| | | Endocervical<br>Only | Urethral<br>Only | Both<br>Positive | | Swab | Urine |
| 138 | Positive | 79 | 0 | 59 | N/A | Pos | Pos |
| 11 | Positive | 8 | 0 | 3 | N/A | Pos | Neg |
| 8 | Positive | 3 | 4 | 1 | N/A | Neg | Pos |
| 9 | Positive | | 8 | 1 | N/A | Neg | Neg |
| 1 | Positive | | 1 | | Pos | Pos | Pos |
| 5 | Negative | | | | Pos | Pos | Pos |
| 2 | Negative | | | | Pos | Pos | Neg |
| 16 | Negative | | | | Neg | Pos | Pos |
| 11 | Negative | | | | Neg | Pos | Neg |
| 15 | Negative | | | | Neg | Neg | Pos |
| 1968 | Negative | | | | N/A | Neg | Neg |

# Table 5 AMPLICOR CT/NG Test for Chlamydia trachomatis Test Result Summary - Female Patients'

' Results from 110 patients without matched CTM and urine results are excluded from the table

| Table 6 | |
|-----------------------------------------------|--|
| AMPLICOR CT/NG Test for Chlamydia trachomatis | |
| Test Result Summary - Male Patients' | |

| No.<br>Patients | Urethral<br>Culture<br>Status | DFA<br>Results | AMPLICOR Results By<br>Specimen Type | |
|-----------------|-------------------------------|----------------|--------------------------------------|-----|
| 208 | Positive | N/A | Pos | Pos |
| 13 | Positive | N/A | Pos | Neg |
| 6 | Positive | N/A | Neg | Neg |
| 14 | Negative | Pos | Pos | Pos |
| 5 | Negative | Pos | Pos | Neg |
| 1 | Negative | Pos | Neg | Pos |
| 44 | Negative | Neg | Pos | Pos |
| 18 | Negative | Neg | Pos | Neg |
| 55 | Negative | Neg | Neg | Pos |
| 1461 | Negative | N/A | Neg | Neg |

' Results from 194 patients without matched CTM and urine results are excluded from the table

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines above a bird-like figure, possibly an eagle, facing left.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 4 1999

Mr. Alex Wesolowski Senior Director Regulatory and Clinical Affairs Roche Molecular Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Re: K973707

> Trade Name: AMPLICOR™ CT/NG Test for Chlamydia trachomatis Regulatory Class: I Product Code: MKZ Dated: May 12, 1999 Received: May 14, 1999

Dear Mr. Wesolowski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): _ K973707

Device Name: AMPLICOR CT/NG Test for Chlamydia trachomatis

Indications For Use:

The AMPLICOR CT/NG Test for Chlamydia trachomatis is a qualitative in vitro test for the detection of Chlamydia trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens as evidence of symptomatic or asymptomatic infection with Chlamydia trachomatis. Chlamydia trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target and by hybridization capture of the amplified target.

Worley Dubose

inical Laboratory Devices 510(k) Number K 973707

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)