(674 days)
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.
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.
The AMPLICOR™ CT/NG Test for Chlamydia trachomatis is a qualitative in vitro test designed to detect Chlamydia trachomatis plasmid DNA in urine (from males and females), endocervical swab specimens (from symptomatic or asymptomatic females), and urethral swab specimens (as evidence of symptomatic or asymptomatic infection). The device utilizes Polymerase Chain Reaction (PCR) amplification and hybridization capture of the amplified target DNA.
Acceptance Criteria and Device Performance
The provided document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity or specificity targets). Instead, it presents the results of clinical performance evaluations against a composite reference standard (culture and DFA). The reported performance metrics are:
| Metric | Value (with 95% CI) |
|---|---|
| CLINICAL PERFORMANCE (Female, combined swab and urine) | |
| Sensitivity | Asymptomatic: 93.1% (88.8-98.4) Symptomatic: 94.3% (89.9-98.7) |
| Specificity | Asymptomatic: 98.0% (97.1-98.8) Symptomatic: 97.7% (96.7-98.6) |
| CLINICAL PERFORMANCE (Male, combined swab and urine) | |
| Sensitivity | Asymptomatic: 92.9% (90.7-95.1) Symptomatic: 92.4% (90.1-94.6) (from total for males, Table 3) |
| Specificity | Asymptomatic: 94.7% (93.9-95.5) Symptomatic: 94.8% (94.1-95.6) (from total for males, Table 3) |
| NON-CLINICAL PERFORMANCE | |
| Analytical Sensitivity (Limit of Detection) | 1 Inclusion Forming Unit (IFU) per test for all 15 Chlamydia serovars |
| Analytical Specificity | Negative results for 132 bacteria, 6 fungi, 1 protozoon, and 11 virus isolates at ≥ 10^4 copies of genomic DNA per test |
| Precision (% Correct Results) | 100% for CTM (0, 1.25, 3.75, 6.25 IFU/test) and Urine (0, 1, 3, 5 IFU/test) specimens |
Study Details
-
Sample sizes used for the test set and data provenance:
- Total specimens collected: 8521 from 4298 patients.
- Specimens included in analysis: 8309 (with Internal Control results used) or 8378 (with Internal Control results not used) after excluding equivocal (143) and repeatedly inhibitory (69) specimens.
- Data Provenance:
- Country of origin: Not explicitly stated, though the study was conducted at "six geographically diverse sites." The submission to the FDA is from a US company.
- Retrospective or Prospective: The clinical study appears to be prospective, as specimens were "obtained from all patients entered into the study," and specific inclusion criteria (e.g., patient not on antibiotics, valid culture result, met storage requirements) were applied.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the clinical study was established by standard culture with cyclohexamide treated McCoy cells stained with fluorescein-labeled monoclonal antibody for C. trachomatis, and for culture-negative swab specimens, DFA (Direct Fluorescent Antibody) for the presence of C. trachomatis.
- The document does not specify the number of experts or their qualifications for performing these reference methods. These are laboratory-based diagnostic tests, typically performed by trained medical technologists or microbiologists.
-
Adjudication method for the test set:
- The primary reference standard was a composite of culture and DFA.
- When the AMPLICOR test results were positive but the composite culture/DFA was negative ("false positive"), alternate PCR testing using oligonucleotide primers targeted for a region of the C. trachomatis MOMP gene was performed. However, the MOMP test results "were not used to calculate the clinical performance characteristics of the test and are reported for information purposes only." This suggests the MOMP assay served as a secondary, confirmatory test for discordant results, but not as part of the primary ground truth adjudication for calculating sensitivity and specificity. There is no mention of a formal expert adjudication panel.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic test, not an AI system interpreted by human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the data presented reflects the standalone performance of the AMPLICOR CT/NG Test for Chlamydia trachomatis as an in vitro diagnostic device. There is no human-in-the-loop element described for making the diagnostic determination.
-
The type of ground truth used:
- The ground truth used was a composite reference standard consisting of:
- Standard cell culture followed by immunofluorescent staining for C. trachomatis.
- Direct Fluorescent Antibody (DFA) for C. trachomatis on culture-negative swab specimens.
- Additionally, an alternate PCR (MOMP gene target) was used for investigational purposes to understand discordant results (AMPLICOR positive, culture/DFA negative), suggesting a form of expanded gold standard or latent class analysis was considered, though not formally incorporated into the primary performance calculations.
- The ground truth used was a composite reference standard consisting of:
-
The sample size for the training set:
- The document does not describe a "training set" in the context of an algorithm or machine learning model. This is a traditional in vitro diagnostic device. The concept of training data is not applicable here. The non-clinical performance studies (analytical sensitivity, specificity, precision) were performed on laboratory-prepared samples.
-
How the ground truth for the training set was established:
- As there is no training set for an algorithm described, this question is not applicable. The non-clinical performance studies used known quantities of C. trachomatis IFU (Inclusion Forming Units) or other microbial isolates as their "ground truth" to determine analytical characteristics.
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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 (908) 253-7200
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.
| C. trachomatis 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 |
| Table 1 |
|---|
| AMPLICOR CT/NG Test for Chlamydia trachomatisCTM Specimen Precision |
| Table 2 |
|---|
| AMPLICOR CT/NG Test for Chlamydia trachomatis |
| Urine Specimen Precision |
| 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%(87.7-98.63) | 98.6%(97.9-99.3) | 10/14 |
| (76) | (1019) | (14) | (4) | (1113) | (95.0%)(87.7-98.63) | (98.6%)(97.9-99.3) | (10/14) | |||||
| CTM | Symptomatic | 94 | 1026 | 15 | 1 | 5 | 0.48% | 1141 | 98.9%(94.3-100.0) | 98.6%(97.8-99.3) | 10/15 | |
| (94) | (1031) | (15) | (1) | (1141) | (98.9%)(94.3-100.0) | (98.6%)(97.8-99.3) | (10/15) | |||||
| Female | URINE | Asymptomatic | 68 | 1004 | 14 | 8 | 15 | 1.46% | 1109 | 89.5%(82.6-96.4) | 98.6%(97.9-99.3) | 10/14 |
| (67) | (1018) | (14) | (10) | (1109) | (87.0%)(79.5-94.5) | (98.6%)(97.9-99.3) | (10/14) | |||||
| URINE | Symptomatic | 82 | 1021 | 24 | 7 | 10 | 0.96% | 1144 | 92.1%(86.5-97.7) | 97.7%(96.8-98.6) | 14/24 | |
| (82) | (1032) | (23) | (7) | (1144) | (92.1%)(86.5-97.7) | (97.8%)(96.9-98.7) | (13/23) | |||||
| Female | Total for Females | 320 | 4070 | 67 | 20 | 30 | 0.73% | 4507 | 94.1%(91.6-96.6) | 98.4%(98.0-98.8) | 44//67 | |
| Female | Total for Females | (319) | (4100) | (66) | (22) | (4507) | (93.5%)(90.9-96.2) | (98.4%)(98.0-98.8) | (43/66) | |||
| Male | CTM | Asymptomatic | 75 | 598 | 14 | 1 | 6 | 0.99% | 694 | 98.7%(92.9-100.0) | 97.7%(96.5-98.9) | 4/14 |
| (75) | (604) | (14) | (1) | (694) | (98.7%)(92.9-1-100.0) | (97.7%)(96.6-98.9) | (4/14) | |||||
| CTM | Symptomatic | 181 | 974 | 49 | 7 | 12 | 1.21% | 1223 | 96.3%(93.6-99.0) | 95.2%(93.9-96.5) | 31/49 | |
| (180) | (986) | (49) | (8) | (1223) | (95.7%)(92.9-98.6) | (95.3%)(94.0-96.6) | (31/49) | |||||
| Male | URINE | Asymptomatic | 69 | 603 | 27 | 6 | 0 | 0.00% | 705 | 92.0%(85.9-98.1) | 95.7%(94.1-97.3) | 14/27 |
| (69) | (603) | (27) | (6) | (705) | (92.0%)(85.9-98.1) | (95.7%)(94.1-97.3) | (14/27) | |||||
| URINE | Symptomatic | 162 | 958 | 85 | 23 | 21 | 2.10% | 1249 | 87.6%(82.8-92.3) | 91.9%(90.2-93.5) | 60/85 | |
| (160) | (981) | (83) | (25) | (1249) | (86.5%)(81.6-91.4) | (92.2%)(90.6-93.8) | (58/83) | |||||
| Male | Total for Males | 487 | 3133 | 175 | 37 | 39 | 1.22% | 3871 | 92.9%(90.7-95.1) | 94.7%(93.9-95.5) | 109/175 | |
| Male | Total for Males | (484) | (3174) | (173) | (40) | (3871) | (92.4%)(90.1-94.6) | (94.8%)(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 | %Inhibitory | No.Inhib. | Sensitivity(95% CI) | Specificity(95% CI) | MOMP+/FP |
|---|---|---|---|---|---|---|---|---|
| Female | CTM + URINE | Asymp | 1123(1121) | 0.00% | 0 | 93.1%(88.8-98.4) | 98.0%(97.1-98.8) | 16/21(16/21) |
| Symptomatic | 1172(1170) | 0.19% | 2 | 94.3%(89.9-98.7) | 97.7%(96.7-98.6) | 14/25(14/25) | ||
| CTM | Asymp | 1113(1113) | 0.00% | 0 | 87.4%(80.4-94.3) | 98.6%(97.9-99.3) | 11/14(11/14) | |
| Symptomatic | 1141(1141) | 0.48% | 5 | 94.0%(89.3-98.7) | 98.6%(97.8-99.3) | 11/15(11/15) | ||
| Total CTM | 2254(2254) | 0.24% | 5 | 90.9%(86.8-95.0) | 98.6%(98.1-99.1) | 22/29(22/29) | ||
| URINE | Asymp | 1109(1109) | 1.46% | 15 | 84.3%(76.5-92.2) | 98.8%(98.1-99.5) | 10/12(10/12) | |
| Symptomatic | 1144(1144) | 0.96% | 10 | 89.5%(83.3-95.6) | 98.0%(97.1-98.8) | 14/21(14/21) | ||
| Total Urine | 2253(2253) | 1.21 | 25 | 87.1%(82.2-92.0) | 98.4%(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.Patients | CultureStatus | Endocervical And Urethral CultureResults | DFAResults | AMPLICORResults bySpecimen Type | |||
|---|---|---|---|---|---|---|---|
| EndocervicalOnly | UrethralOnly | BothPositive | 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.Patients | UrethralCultureStatus | DFAResults | AMPLICOR Results BySpecimen 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 (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__________________________________________________________________________________________________________________________________________________________________________
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)
§ 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).