ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Device Facts
| Record ID | K973718 |
|---|---|
| Device Name | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
| Applicant | Roche Molecular Systems, Inc. |
| Product Code | MKZ · Microbiology |
| Decision Date | Dec 15, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3120 |
| Device Class | Class 1 |
Indications for Use
The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis is a qualitative in vitro 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 or asymptomatic infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS AMPLICOR Analyzer.
Device Story
In vitro diagnostic test for C. trachomatis; utilizes PCR amplification of target plasmid DNA and hybridization capture. Input: urine, endocervical swabs, or male urethral swabs. Processing: COBAS AMPLICOR Analyzer automates amplification, nucleic acid hybridization, and colorimetric detection. Includes Internal Control to identify PCR inhibition. Output: qualitative detection of C. trachomatis DNA via absorbance measurement of a chromophore (3,3',5,5'-tetramethylbenzidine oxidized by hydrogen peroxide/horseradish peroxidase). Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing Chlamydia infection. Benefits include automated, high-throughput detection of genetic material compared to traditional culture methods.
Clinical Evidence
Clinical study at six sites with 8,523 specimens from 4,277 patients. Compared COBAS AMPLICOR results to composite reference (culture, sub-culture, DFA). Sensitivity and specificity varied by specimen type and symptom status; overall female sensitivity ~93.1%, specificity ~97.9%; male sensitivity ~93.0%, specificity ~94.7%. Internal control used to identify inhibited specimens. MOMP gene PCR used for supplemental analysis of discordant results.
Technological Characteristics
Multiplex PCR-based in vitro diagnostic test. Detection via colorimetric absorbance measurement (3,3',5,5'-tetramethylbenzidine/hydrogen peroxide/horseradish peroxidase). Automated processing on COBAS AMPLICOR Analyzer. Includes Internal Control for PCR inhibition. Analyzes cryptic plasmid DNA of C. trachomatis.
Indications for Use
Indicated for detection of C. trachomatis plasmid DNA in males and females (urine, endocervical swabs, male urethral swabs) to diagnose symptomatic or asymptomatic infection.
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).
Predicate Devices
- AMPLICOR Chlamydia trachomatis Test
- COBAS AMPLICOR Chlamydia trachomatis Test
Submission Summary (Full Text)
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510(k) Summary
1973718
# DEC 15 1998
# COBAS AMPLICOR™ CT/NG Test for Chlamydia trachomatis Roche Molecular Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-1760 (908) 253-7200
#### Intended Use:
The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis is a qualitative in vitro 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. truchomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS AMPLICOR Analyzer.
#### Description of the Device:
The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis is a multiplex in vitro diagnostic test performed on the COBAS AMPLICOR Analyzer. The COBAS AMPLICOR Analyzer automates the annolification, the nucleic acid hybridization, and the colorimetric detection procedures of the Test. The COBAS 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 COBAS AMPLICOR CTNG Test for Chlamydia trachomatis is substantially equivalent to other commercially available in vitro diagnostic devices for the detection of Chiamydia 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 COBAS AMPLICOR CTNG 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 COBAS AMPLICOR Chlamydia trachomatis Test has been shown to be substantially equivalent to cell culture methods.
The COBAS 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 COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis allow the automated multiplex amplification of Chlamydia 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 detection reactions that are based on the absorbance measurement of a chromophore that is produced by the oxidation of 3,3',5,5'-tetramethybenzidine by hydrogen peroxide in the presence of horseradish peroxidase.
### Non-Clinical Performance:
The COBAS 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 COBAS AMPLICOR CT/NG Test for C. trachomatis was tested against 132 bacteria, 6 fungi, 1 protozoon and 11 virus isolates that may be isolated from the urogenital tract. The 1.52 backers, or c. g. 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 COBAS AMPLICOR CT/NG Test for Chlamydia Irachomatis on the COBAS AMPLICOR Analyzer was determined for a panel of culture transport media specimens containing 0, 1.25, 3.75 and 6.25 Chlamydia trachomatis 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 COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis gave 100% qualitatively correct results across all specimen types, concentrations and sites. The results of this study are presented in Tables 1 and 2.
| | <i>C. trachomatis Spiked CTM (IFU/test)</i> | | | |
|-------------------|---------------------------------------------|-------|-------|-------|
| | 0 | 1.25 | 3.75 | 6.25 |
| Replicates | 72 | 36 | 36 | 36 |
| % Correct Results | 100 | 100 | 100 | 100 |
| Mean A660 | 0.005 | 3.250 | 3.153 | 3.176 |
| Minimum A660 | 0.000 | 2.732 | 2.686 | 2.681 |
| Maximum A660 | 0.018 | 4.000 | 3.610 | 3.962 |
Table 1 COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis CTM Specimen Reproducibility
| <i><b>Table 2</b></i> |
|-------------------------------------------------------------------|
| <i><b>COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis</b></i> |
| <i><b>Urine Specimen Reproducibility</b></i> |
| | C. trachomatis Spiked CTM (IFU/test) | | | |
|-----------------------|--------------------------------------|-------|-------|-------|
| | 0 | 1 | 3 | 5 |
| Replicates | 72 | 36 | 36 | 36 |
| % Correct Qualitative | 100 | 100 | 100 | 100 |
| Mean A660 | 0.004 | 3.393 | 3.268 | 3.270 |
| Minimum A660 | 0.000 | 2.691 | 2.381 | 2.264 |
| Maximum A660 | 0.023 | 4.000 | 4.000 | 4.000 |
### Clinical Performance:
The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis was evaluated in a clinical study conducted at six geographically diverse sites. Swab (endocervical 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 COBAS Test were tested by DFA for the presence of C. trachomatis. The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis was performed on all endocervical swab and urine specimens obtained from female patients,
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and all urethral swabs and urine specimens from male patients. COBAS testing was repeated for all specimens with initial results in the range of 0.2 to 0.8 Awa and when IC results were inhibited (negative).
A total of 8523 specimens collected from 4277 patients met the criteria for 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 was entered into the study for 4201 patients; a urine specimen only was entered into the study from 76 patients. Of the 8523 specimens included in the study, 45 specimens gave initial test results in the Equivocal Range and were excluded from the data analyses. Two specimens that were initially inhibitory gave results in the Equivocal Range upon repeat testing. These specimens are excluded from the analyses when the Internal Control was used but included in the analyses when the Internal Control was not used. In addition, 79 specimens were repeatedly inhibitory and were excluded from the data analyses which include the use of the Internal Control because the results were not interpretable. Therefore, 8397 specimens were included in the analyses when the Internal Control result was used and a total of 8478 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 8478 swab and urine specimens to the composite results of the comparative tests (culture, sub-culture and DFA). Alternate PCR testing using oliognucleotide primers targeted for a region of the C. trachomatis MOMP gene was performed on COBAS 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 266 COBAS AMPLICOR positive, culture/DFA negative specimens that were classified as false positive results in this study, 185 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 COBAS 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 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 results. False Positive (FP) represents the number of culture and DFA negative, COBAS positive results.
Table 4 shows the clinical performance of the COBAS AMPLICOR CT/NG Test for Chlamvaia 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 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 COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis. The testing of both swab and urine specimens by the COBAS 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 COBAS 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 specinen types may be useful for increasing the confidence in a positive result using the COBAS AMPLICOR CT/NG Test for Chlumydia trachomatis, particularly for low prevalence populations.
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The clinical sensitivity and specificity of the COBAS 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 Chlamydia-related sequelae. In the clinical study described here, 24.4% of COBAS positive results were from patients with negative cultures and DFA tests. The significance of those results that were COBAS positive, but culture and DFA negative is unknown. A proportion of these COBAS positive specimens (63.8%) 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. | % Repeatedly Inhibitory | Total | Sensitivity (95% CI) | Specificity (95% CI) | MOMP+/FP |
|-------------------|----------|--------------|--------------|----------------|--------------|------------|------------|-------------------------|----------------|------------------------------------------------|------------------------------------------------|----------------------|
| Female | CTM | Asymptomatic | 75<br>(75) | 1013<br>(1017) | 17<br>(16) | 4<br>(4) | 2 | 0.20% | 1111<br>(1112) | 94.9%<br>(93.6-96.2)<br>(94.9%)<br>(93.6-96.2) | 98.3%<br>(97.6-99.1)<br>(98.5%)<br>(97.7-99.2) | 9/17<br>(10/16) |
| | | Symptomatic | 93<br>(93) | 1025<br>(1031) | 21<br>(21) | 4<br>(4) | 6 | 0.58% | 1149<br>(1149) | 95.9%<br>(94.6-97.2)<br>(95.9%)<br>(94.6-97.2) | 98.0%<br>(97.1-98.8)<br>(98.0%)<br>(97.2-98.8) | 11/21<br>(11/21) |
| Female | URINE | Asymptomatic | 70<br>(70) | 1011<br>(1023) | 18<br>(18) | 7<br>(8) | 13 | 1.26% | 1119<br>(1119) | 90.9%<br>(84.5-97.3)<br>(89.7%)<br>(83.0-96.5) | 98.3%<br>(97.4-99.1)<br>(98.3%)<br>(97.5-99.1) | 13/18<br>(13/18) |
| | | Symptomatic | 84<br>(84) | 1018<br>(1030) | 33<br>(33) | 9<br>(9) | 12 | 1.15% | 1156<br>(1156) | 90.3%<br>(84.3-96.3)<br>(90.3%)<br>(84.3-96.3) | 96.9%<br>(95.8-97.9)<br>(96.9%)<br>(95.9-97.9) | 14/33<br>(14/33) |
| Total for Females | | | 322<br>(322) | 4067<br>(4101) | 89<br>(88) | 24<br>(25) | 33 | 0.73% | 4535<br>(4536) | 93.1%<br>(90.4-95.7)<br>(92.8%)<br>(90.1-95.5) | 97.9%<br>(97.4-98.3)<br>(97.9%)<br>(97.5-98.3) | 47/89<br>(48/88) |
| Male | CTM | Asymptomatic | 76<br>(76) | 608<br>(612) | 14<br>(14) | 1<br>(1) | 4 | 0.65% | 703<br>(703) | 98.7%<br>(97.1-100)<br>(98.7%)<br>(97.1-100) | 97.7%<br>(96.6-98.9)<br>(97.8%)<br>(96.6-98.9) | 5/14<br>(5/14) |
| | | Symptomatic | 183<br>(183) | 977<br>(994) | 56<br>(54) | 6<br>(6) | 14 | 1.40% | 1236<br>(1237) | 96.8%<br>(94.3-99.3)<br>(96.8%)<br>(94.3-99.3) | 94.6%<br>(93.2-96.0)<br>(94.8%)<br>(93.5-96.2) | 32/56<br>(32/54) |
| Male | URINE | Asymptomatic | 71<br>(71) | 616<br>(617) | 24<br>(24) | 8<br>(8) | 1 | 0.16% | 720<br>(720) | 89.9%<br>(83.2-96.5)<br>(89.9%)<br>(83.2-96.5) | 96.3%<br>(94.8-97.7)<br>(96.3%)<br>(94.8-97.7) | 14/24<br>(14/24) |
| | | Symptomatic | 173<br>(168) | 976<br>(1004) | 83<br>(80) | 23<br>(30) | 27 | 2.63% | 1282<br>(1282) | 88.3%<br>(83.8-92.8)<br>(84.8%)<br>(79.9-89.8) | 92.2%<br>(90.5-93.8)<br>(92.6%)<br>(91.1-94.2) | 62/83<br>(60/80) |
| Total for Males | | | 503<br>(498) | 3177<br>(3227) | 177<br>(172) | 38<br>(45) | 46 | 1.41% | 3941<br>(3942) | 93.0%<br>(90.8-95.1)<br>(91.7%)<br>(89.4-94.0) | 94.7%<br>(94.0-95.5)<br>(94.9%)<br>(94.2-95.7) | 113/177<br>(111/172) |
Table 4 Clinical Performance Of COBAS AMPLICOR CT/NG Test for Chlamydia trachomutis Including and Excluding the Internal Controll
' 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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| Specimen | Symptom | Total | %<br>Inhibitory | No.<br>Inhib. | Sensitivity | Specificity<br>(95% CI) | MOMP+/FF- |
|----------------|-------------|-------------------------|-----------------|---------------|--------------------------------------------------|-------------------------------------------------|------------------|
| CTM + URINE | Asymp | 1126<br>(1227) | 0.00% | 0 | 90.8%<br>(84.7-96.9)<br>90.8%<br>(84.7-96.9) | 97.4%<br>(96.4-98.4)<br>(97.7%)<br>(96.9-98.6) | 18/27<br>(18/26) |
| | Symptomatic | 1169<br>(1169) | 0.10% | 1 | 95.2%<br>(94.0-96.4)<br>95.2%<br>(94.0-96.4) | 96.4%<br>(95.3-97.5)<br>(96.4%)<br>(95.3-97.5) | 15/38<br>(15/38) |
| CTM | | Asymp<br>1111<br>(1112) | 0.20% | 2 | 87.2%<br>(80.2-94.3)<br>87.2%<br>(80.2-94.3) | 98.3%<br>(97.6-99.1)<br>(98.4%)<br>(97.7-99.2) | 11/17<br>(12/16) |
| | Symptomatic | 1149<br>(1149) | 0.58% | 6 | 91.3%<br>(85.8-96.7)<br>91.3%<br>(85.8-96.7) | 98.1%<br>(97.2-98.9)<br>(98.1%)<br>(97.3-98.9) | 16/20<br>(12/20) |
| Totals - CTM | | 2260<br>(2261) | 0.39% | 8 | (89.4%)<br>(85.0-93.8)<br>(89.4%)<br>(85.0-93.8) | 98.2%<br>(97.6-98.8)<br>(98.3%)<br>(97.7-98.8)) | 27/37<br>(24/36) |
| URINE | | Asymp<br>1119<br>(1119) | 1.26% | 13 | 85.7%<br>(78.2-93.2)<br>(84.7%)<br>(77.1-92.4) | 98.4%<br>(97.7-99.2)<br>(98.5%)<br>(97.7-99.2) | 13/16<br>(13/16) |
| | Symptomatic | 1156<br>(1156) | 1.15% | 12 | 87.9%<br>(81.4-94.3)<br>(87.9%)<br>(81.4-94.3) | 97.1%<br>(96.1-98.1)<br>(97.2%)<br>(96.2-98.2) | 14/30<br>(14/30) |
| Totals - Urine | | 2275<br>(2275) | 1.21 | 25 | 86.9%<br>(82.0-91.8)<br>(86.4%)<br>(81.5-91.4) | 97.8%<br>(97.1-98.4)<br>(97.8%)<br>(97.2-98.4)) | 27/36<br>(27/36) |
#### Table S Performance of COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis vs Patient Status' Female Patients Including and Excluding the Internal Control²
4Culture and DFA results in this table include endocervical and urchral results 4 Test results without the Internal Control shown in parentheses.
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| No.<br>Patients | Culture<br>Status | Endocervical And Urethral Culture<br>Results | | | DFA<br>Results | COBAS<br>AMPLICOR<br>Results by<br>Specimen Type | |
|-----------------|-------------------|----------------------------------------------|------------------|------------------|----------------|--------------------------------------------------|-------|
| | | Endocervical<br>Only | Urethral<br>Only | Both<br>Positive | | Swab | Urine |
| 146 | + | 85 | 2 | 59 | N/A | + | + |
| 11 | + | 8 | 0 | 3 | N/A | + | - |
| 7 | + | 2 | 4 | 1 | N/A | - | + |
| 11 | + | 1 | 8 | 2 | N/A | - | - |
| 6 | - | | | | + | + | + |
| 2 | - | | | | + | + | - |
| 1 | - | | | | + | - | - |
| 18 | - | | | | - | + | + |
| 18 | - | | | | - | + | - |
| 26 | - | | | | - | - | + |
| 1965 | - | | | | N/A | - | - |
## Table 6 COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis Test Result Summary - Female Patients'
1 Results from 85 patients without matched CTM and urine results are excluded from the table
# Table 7 COBAS AMPLICOR CT/NG Test for Chlamydia truchomatis Test Result Summary - Male Patients
| No.<br>Patients | Urethral<br>Culture<br>Status | DFA<br>Results | COBAS AMPLICOR Results<br>By Specimen Type | |
|-----------------|-------------------------------|----------------|--------------------------------------------|-------|
| | | | Swab | Urine |
| 215 | + | N/A | + | + |
| 20 | + | N/A | + | - |
| 4 | + | N/A | - | - |
| 16 | - | + | + | + |
| 3 | - | + | + | - |
| 48 | - | - | + | + |
| 17 | - | - | + | - |
| 51 | - | - | - | + |
| 2 | - | - | Inhib | Inhib |
| 1503 | - | N/A | - | - |
· Results from 140 patients without matched CTM and urine results are excluded from the table
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Image /page/7/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of a human figure, with three stylized profiles facing to the right. Below the profiles are two wavy lines.
DEC 15 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Alex Wesolowski Sr. Director, Regulatory and Clinical Affairs Roche Molecular Systems, Inc. 1080 U.S. Highway 202 Somerville, NJ 08876-3771
Re: K973718
Trade Name: Roche COBAS Amplicor CT/NG Test for Chlamydia trachomatis Regulatory Class: I Product Code: MKZ Dated: September 18, 1998 Received: September 22, 1998
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 QS 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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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_ 1 _of_1 _
510(k) Number (if known): K973718
Device Name: COBAS Amplicor CT/NG Test for C. trachomatis
Indications For Use:
The COBAS AMPLICOR CT/NG Test for Chlamydia trachomatis is a qualitative in vitro 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 or asymptomatic infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS AMPLICOR Analyzer.
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
Division Sign Off
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973718
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
