(90 days)
Not Found
No
The device description details a nucleic acid amplification test (NAAT) with specific biochemical and kinetic detection methods. There is no mention of AI or ML in the device description, intended use, or performance studies. The data analysis involves cut-off values and kinetic profiles, which are standard for this type of assay and do not indicate AI/ML.
No
This device is for in vitro qualitative detection and differentiation of ribosomal RNA to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease. It is a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is used "to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease."
No
The device description clearly outlines a complex in vitro diagnostic assay involving chemical reactions, magnetic microparticles, and a dedicated hardware system (Panther System) for automation and detection. While software is mentioned as part of the Panther system, the core of the medical device is the assay and the hardware that processes it, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Aptima Combo 2 Assay is for "in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease". The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Specimen Types: The assay is designed to test various specimens collected from the human body (endocervical, vaginal, male urethral swabs, urine), which are then analyzed outside the body.
- Device Description: The description details a laboratory process involving sample preparation, target capture, amplification (TMA), and detection (DKA) of nucleic acids from these specimens. These are all procedures performed in a laboratory setting on biological samples.
- Performance Studies: The document describes clinical studies where the assay's performance is evaluated against a comparator method using collected patient samples. This is typical for the validation of an IVD.
The entire description points to a device that is used to perform tests on biological samples in vitro to provide information for the diagnosis of disease.
N/A
Intended Use / Indications for Use
The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Panther® System as specified.
On the Panther System, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt® Solution, patient-collected vaginal swab specimens, and female and male urine specimens.
Product codes
LSL, MKZ
Device Description
Clearance of this pre-market application will add female urine as an acceptable specimen type using the Aptima Combo 2 assay on the Panther system.
The Aptima Combo 2 Assay combines the technologies of target capture, Transcription-Mediated Amplification (TMA), and Dual Kinetic Assay (DKA). Specimens are collected and transferred into their respective specimen transport tubes. The transport solutions in these tubes release the rRNA targets and protect them from degradation during storage. When the Aptima Combo 2 Assay is performed in the laboratory, the target rRNA molecules are isolated from specimens by use of capture oligomers via target capture that utilizes magnetic microparticles. The capture oligomers contain sequences complementary to specific regions of the target molecules as well as a string of deoxyadenosine residues. A separate capture oligomer is used for each target. During the hybridization step, the sequence specific regions of the capture oligomers bind to specific regions of the target molecules. The capture oligomer:target complex is then captured out of solution by decreasing the temperature of the reaction to room temperature. This temperature reduction allows hybridization to occur between the deoxyadenosine region on the capture oligomer and the poly-deoxythymidine molecules that are covalently attached to the magnetic particles. The microparticles, including the captured target molecules bound to them, are pulled to the side of the reaction vessel using magnets and the supernatant is aspirated. The particles are washed to remove residual specimen matrix that may contain amplification reaction inhibitors. After the target capture steps are completed, the specimens are ready for amplification.
Target amplification assays are based on the ability of complementary oligonucleotide primers to specifically anneal and allow enzymatic amplification of the target nucleic acid strands. The Aptima Combo 2 Assay replicates a specific region of the 23S rRNA from CT and a specific region of the 16S rRNA from GC via DNA intermediates. A unique set of primers is used for each target molecule. Detection of the rRNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded chemiluminescent DNA probes, which are complementary to a region of each target amplicon, are labeled with different acridinium ester molecules. The labeled DNA probes combine with amplicon to form stable RNA:DNA hybrids. The Selection Reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal from unhybridized probe. During the detection step, light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer, and are reported as Relative Light Units (RLU). In DKA, differences in the kinetic profiles of the CT and GC labeled probes allow for the differentiation of signal; kinetic profiles are derived from measurements of photon output during the detection read time. The chemiluminescent detection for CT signal has very rapid kinetics and has the "flasher" kinetic type. The chemiluminescent detection reaction for GC signal is relatively slower and has the "glower" kinetic type. Assay results are determined by a cut-off based on the total RLU and the kinetic curve type.
The Aptima Combo 2 assay has been designed for and validated on the Panther system. The Panther system is an integrated hardware and software system that together with the Aptima Combo 2 assay fully automates all the steps necessary to perform the assay from sample preparation through amplification of nucleic acid, detection, data reduction and amplicon inactivation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urogenital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A retrospective study was conducted that used results and remnant urine samples from women enrolled for a previously completed prospective study of the Aptima Combo 2 assay on the Panther system. Specimens originated from symptomatic and asymptomatic women (n=2640) enrolled from 17 geographically and ethnically diverse US clinical sites, including family planning, academic center, and public health clinics. In the previous study, all female urine samples were tested with the Aptima Combo 2 assay on the Panther system, and with two FDA-cleared comparator nucleic acid amplification tests (NAATs). For the current study, previous study testing results were re-analyzed to assess the performance of the Aptima Combo 2 assay on the Panther system in urine samples relative to an FDA-agreed upon composite comparator algorithm (CCA).
The CCA was determined for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) separately using urine test results from up to 3 FDA-cleared CT/GC NAATs. When 2 out of 3 of the NAATs were positive, the CCA was considered positive. When 2 out of 3 of the NAATs were negative, the CCA was considered negative. If the two comparator NAAT results for urine samples did not determine the CCA, additional (tie-breaker) testing was performed with a third FDA-cleared CT/GC NAAT using remnant urine samples from the previous study to determine the CCA.
Of the 2640 subjects enrolled, 42 subjects were withdrawn. Of the 2598 non-withdrawn subjects 2581 had urine samples tested with the Aptima Combo 2 Assay on the Panther System in accordance with the Aptima Combo 2 Assay package insert instructions. Seventeen subjects had urine samples that were withdrawn or not collected (missing both CT and GC Aptima Combo 2 Assay (Panther System) results). Samples with initial invalid, equivocal, or error results were retested. All 2581 samples had final valid results after required retesting. One sample had a repeat CT equivocal result and one sample had a repeat GC equivocal result.
Of the 2581 subjects that had valid Aptima Combo 2 Assay (Panther System) results, 2580 subjects had a conclusive CT and/or GC composite comparator status and were evaluable for performance; one subject had unknown composite comparator status for both CT and GC and was not evaluable. One evaluable subject had a final equivocal CT result (negative GC result), and one evaluable subject had a final equivocal GC result (negative CT result).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance, Clinical Study 3. Female urine Specimen Clinical Study
Sample Size: Retrospective study of 2640 women (2580 evaluable subjects).
Key Results: Performance characteristics for detection of CT and GC in female urine samples were calculated separately.
For CT (n=1379 symptomatic): PPA 99.1% (95% CI 95.0-99.8), NPA 99.8% (95% CI 99.4-100).
For CT (n=1193 asymptomatic): PPA 98.5% (95% CI 91.9-99.7), NPA 99.7% (95% CI 99.2-99.9).
For GC (n=1383 symptomatic): PPA 95.0% (95% CI 76.4-99.1), NPA 100% (95% CI 99.7-100).
For GC (n=1196 asymptomatic): PPA 100% (95% CI 70.1-100), NPA 100% (95% CI 99.7-100).
In Clinical Study 3, female urine detected 8.3% fewer CT infections than vaginal and endocervical swab specimens and 12.9% fewer GC infections than vaginal swab specimens and 15.2% fewer GC infections than endocervical swab specimens when compared using the PIS algorithm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA), Negative Percent Agreement (NPA)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY Aptima Combo 2 Assay (Panther System)
I. SUBMITTER
Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121
| Contact Person: | Jeffrey Hergesheimer, MS, RAC
Regulatory Affairs Manager |
|-----------------|-------------------------------------------------------------|
| | Jeffrey.Hergesheimer@Hologic.com |
| | Phone: (858) 410-8536 |
| | Fax: (858) 410-5557 |
Date Prepared: March 7, 2018
II. DEVICE
| Proprietary Name of Device: | Aptima Combo 2 Assay (Panther System) |
|---|---|
| Classification Name: | DNA Reagents, Neisseria, |
| DNA Probe, Nucleic Acid Amplification, Chlamydia | |
| Regulation Number: | 21 CFR 866.3390 and 866.3120 |
| Regulatory Class: | Class II |
| Product Code: | LSL, MKZ |
III. PREDICATE DEVICE
The predicate device is the Aptima Combo 2 Assay (Panther System); K132251, cleared October 17, 2013.
17, 2013.
IV. DEVICE DESCRIPTION
Clearance of this pre-market application will add female urine as an acceptable specimen type using the Aptima Combo 2 assay on the Panther system.
Principles of the Procedure
1
The Aptima Combo 2 Assay combines the technologies of target capture, Transcription-Mediated Amplification (TMA), and Dual Kinetic Assay (DKA). Specimens are collected and transferred into their respective specimen transport tubes. The transport solutions in these tubes release the rRNA targets and protect them from degradation during storage. When the Aptima Combo 2 Assay is performed in the laboratory, the target rRNA molecules are isolated from specimens by use of capture oligomers via target capture that utilizes magnetic microparticles. The capture oligomers contain sequences complementary to specific regions of the target molecules as well as a string of deoxyadenosine residues. A separate capture oligomer is used for each target. During the hybridization step, the sequence specific regions of the capture oligomers bind to specific regions of the target molecules. The capture oligomer:target complex is then captured out of solution by decreasing the temperature of the reaction to room temperature. This temperature reduction allows hybridization to occur between the deoxyadenosine region on the capture oligomer and the poly-deoxythymidine molecules that are covalently attached to the magnetic particles. The microparticles, including the captured target molecules bound to them, are pulled to the side of the reaction vessel using magnets and the supernatant is aspirated. The particles are washed to remove residual specimen matrix that may contain amplification reaction inhibitors. After the target capture steps are completed, the specimens are ready for amplification.
Target amplification assays are based on the ability of complementary oligonucleotide primers to specifically anneal and allow enzymatic amplification of the target nucleic acid strands. The Aptima Combo 2 Assay replicates a specific region of the 23S rRNA from CT and a specific region of the 16S rRNA from GC via DNA intermediates. A unique set of primers is used for each target molecule. Detection of the rRNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded chemiluminescent DNA probes, which are complementary to a region of each target amplicon, are labeled with different acridinium ester molecules. The labeled DNA probes combine with amplicon to form stable RNA:DNA hybrids. The Selection Reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal from unhybridized probe. During the detection step, light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer, and are reported as Relative Light Units (RLU). In DKA, differences in the kinetic profiles of the
2
CT and GC labeled probes allow for the differentiation of signal; kinetic profiles are derived from measurements of photon output during the detection read time. The chemiluminescent detection for CT signal has very rapid kinetics and has the "flasher" kinetic type. The chemiluminescent detection reaction for GC signal is relatively slower and has the "glower" kinetic type. Assay results are determined by a cut-off based on the total RLU and the kinetic curve type.
Assay Components
The reagents required to perform the Aptima Combo 2 assay (Panther System) are available in two kit sizes (100- and 250-tests). The kits are packaged in 3 boxes containing 11 reagents which are required for sample processing. A description of the components that are required to perform the Aptima Combo 2 assay are detailed in Table 1. In addition, there are two ancillary kits required to run the assay (Table 2), and four collection kits utilized for collection and transfer of specimens prior to testing on the Panther system (Table 3).
| Box | Components Description |
|---|---|
| 1 | Amplification Reagent |
| Enzyme Reagent | |
| Probe Reagent | |
| Target Capture Reagent B | |
| 2 | Amplification Reconstitution Solution |
| Enzyme Reconstitution Solution | |
| Probe Reconstitution Solution | |
| Selection Reagent | |
| Target Capture Reagent | |
| 3 | Aptima Positive Control CT/Neg Control GC |
| Aptima Positive Control GC/Neg Control CT |
Table 1: Reagents Required to Perform the Aptima Combo 2 Assay
Table 2: Ancillary Kits Required to Perform the Aptima Combo 2 Assay
| Aptima Assay Fluids Kit |
|---|
| Aptima Auto Detect Kit |
3
Table 3: Specimen Collection Kits Available for Use with the Aptima Combo 2 Assay
Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens.
Aptima Vaginal Swab Specimen Collection Kit
Aptima Multitest Swab Specimen Collection Kit For Aptima Combo 2 Assay. Aptima Multitest Swab Specimen Collection Kit has been validated for the collection of vaginal swab specimen. Aptima Urine Specimen Collection Kit for Male and Female Urine
Specimens
Aptima Specimen Transfer Kit
Instrumentation
The Aptima Combo 2 assay has been designed for and validated on the Panther system. The Panther system is an integrated hardware and software system that together with the Aptima Combo 2 assay fully automates all the steps necessary to perform the assay from sample preparation through amplification of nucleic acid, detection, data reduction and amplicon inactivation.
V. INDICATIONS FOR USE
Intended Use
The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Panther® System as specified.
On the Panther System, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt® Solution, patient-collected vaginal swab specimens, 1 and female and male urine specimens.
1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal and multitest swab specimen collection kits are not for home use.
4
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A comparison of the Aptima Combo 2 assay (Panther System) with the addition of the female urine specimen type to the predicate device, Aptima Combo 2 assay (Panther System) (K132251), is summarized in Table 4 (similarities) and Table 5 (differences).
| Table 4: Similarities Between Predicate Device and Subject Device | ||
|---|---|---|
| Item | Aptima Combo 2 Assay | |
| (Panther System) | ||
| (Predicate Device, K132251) | Aptima Combo 2 Assay | |
| (Panther System) | ||
| (Subject Device, K180681) | ||
| Technology Principle | ||
| of Operation | Target Capture (TC), Transcription- | |
| Mediated Amplification (TMA), | ||
| Hybridization Protection Assay (HPA) | Same | |
| Platform | Automated Panther System | Same |
| Function | Detection and differentiation of rRNA | |
| from Chlamydia trachomatis and | ||
| Neisseria gonorrhoeae | Same | |
| Organisms Detected | Chlamydia trachomatis (CT) and/or | |
| Neisseria gonorrhoeae (GC) | Same | |
| Patient Population | Symptomatic and asymptomatic | |
| individuals | Same |
Table 4: Similarities Between Predicate Device and Subject Device
Table 5: Differences Between Predicate Device and Subject Device
| Item | Aptima Combo 2 Assay
(Panther System)
(Predicate Device, K132251) | Aptima Combo 2 Assay
(Panther System)
(Subject Device, K180681) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Aptima Combo 2 Assay is a target
amplification nucleic acid probe test
that utilizes target capture for the in
vitro qualitative detection and
differentiation of ribosomal RNA
(rRNA) from Chlamydia trachomatis
(CT) and/or Neisseria gonorrhoeae
(GC) to aid in the diagnosis of
chlamydial and/or gonococcal
urogenital disease using the Panther
System as specified. On the Panther
System, the assay may be used to test
the following specimens from
symptomatic and asymptomatic
individuals: clinician-collected
endocervical, vaginal and male | The Aptima Combo 2 Assay is a target
amplification nucleic acid probe test
that utilizes target capture for the in
vitro qualitative detection and
differentiation of ribosomal RNA
(rRNA) from Chlamydia trachomatis
(CT) and/or Neisseria gonorrhoeae
(GC) to aid in the diagnosis of
chlamydial and/or gonococcal
urogenital disease using the Panther
System as specified. On the Panther
System, the assay may be used to test
the following specimens from
symptomatic and asymptomatic
individuals: clinician-collected
endocervical, vaginal and male |
5
| Item | Aptima Combo 2 Assay
(Panther System)
(Predicate Device, K132251) | Aptima Combo 2 Assay
(Panther System)
(Subject Device, K180681) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | urethral swab specimens, clinician-
collected gynecological specimens
collected in the PreservCyt Solution,
patient-collected vaginal swab
specimens1 and male urine specimens.
1Patient-collected vaginal swab specimens are
an option for screening women when a pelvic
exam is not otherwise indicated. The vaginal
swab specimen collection kit is not for home
use. | urethral swab specimens, clinician-
collected gynecological specimens
collected in the PreservCyt Solution,
patient-collected vaginal swab
specimens,1 and female and male urine
specimens.
1Patient-collected vaginal swab specimens are
an option for screening women when a pelvic
exam is not otherwise indicated. The vaginal
and multitest swab specimen collection kit is
not for home use. |
| Specimen Types | Female specimens:
Vaginal swab Endocervical swab ThinPrep in PreservCyt solution
Male Specimens:
Urethral Swab Urine | Female specimens:
Vaginal swab Endocervical swab ThinPrep in PreservCyt solution Urine
Male Specimens:
Urethral Swab Urine |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Clinical Performance
Clinical Study 3. Female urine Specimen Clinical Study
A retrospective study was conducted that used results and remnant urine samples from women enrolled for a previously completed prospective study of the Aptima Combo 2 assay on the Panther system. Specimens originated from symptomatic and asymptomatic women (n=2640) enrolled from 17 geographically and ethnically diverse US clinical sites, including family planning, academic center, and public health clinics. In the previous study, all female urine samples were tested with the Aptima Combo 2 assay on the Panther system, and with two FDAcleared comparator nucleic acid amplification tests (NAATs). For the current study, previous study testing results were re-analyzed to assess the performance of the Aptima Combo 2 assay on the Panther system in urine samples relative to an FDA-agreed upon composite comparator
6
algorithm (CCA). The CCA was determined for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) separately using urine test results from up to 3 FDA-cleared CT/GC NAATs. When 2 out of 3 of the NAATs were positive, the CCA was considered positive. When 2 out of 3 of the NAATs were negative, the CCA was considered negative. If the two comparator NAAT results for urine samples did not determine the CCA, additional (tie-breaker) testing was performed with a third FDA-cleared CT/GC NAAT using remnant urine samples from the previous study to determine the CCA. Results from testing female urine samples with the Aptima Combo 2 assay on the Panther system were compared to the CCA results to establish the positive percent agreement (PPA) and negative percent agreement (NPA) estimates, with corresponding 2-sided 95% Score confidence intervals (CI). Analyses were performed separately for each CT and GC. Results in urine samples by Aptima Combo 2 Assay (Panther System) were also compared with the vaginal and endocervical swab specimens using the patient infected status (PIS) algorithm. In Clinical Study 3, female urine detected 8.3% fewer CT infections than vaginal and endocervical swab specimens and 12.9% fewer GC infections than vaginal swab specimens and 15.2% fewer GC infections than endocervical swab specimens when compared using the PIS algorithm.
Of the 2640 subjects enrolled, 42 subjects were withdrawn. Of the 2598 non-withdrawn subjects 2581 had urine samples tested with the Aptima Combo 2 Assay on the Panther System in accordance with the Aptima Combo 2 Assay package insert instructions. Seventeen subjects had urine samples that were withdrawn or not collected (missing both CT and GC Aptima Combo 2 Assay (Panther System) results). Samples with initial invalid, equivocal, or error results were retested. All 2581 samples had final valid results after required retesting. One sample had a repeat CT equivocal result and one sample had a repeat GC equivocal result.
Of the 2581 subjects that had valid Aptima Combo 2 Assay (Panther System) results, 2580 subjects had a conclusive CT and/or GC composite comparator status and were evaluable for performance; one subject had unknown composite comparator status for both CT and GC and was not evaluable. One evaluable subject had a final equivocal CT result (negative GC result), and one evaluable subject had a final equivocal GC result (negative CT result). Demographics of the 2580 evaluable subjects is presented in Table 6.
7
| N (%) | |
|---|---|
| Total | 2580 (100) |
| Symptom Status | |
| Asymptomatic | 1196 (46.4) |
| Symptomatic | 1384 (53.6) |
| Age Group | |
| 16 to 17 years | 47 (1.8) |
| 18 to 20 years | 346 (13.4) |
| 21 to 30 years | 1350 (52.3) |
| 31 to 40 years | 550 (21.3) |
| >40 years | 287 (11.1) |
Table 6: Summary of Subject Symptom Status and Age for Samples in the Aptima Combo 2 Assay Evaluation
Of the 2580 evaluable samples tested with the Aptima Combo 2 assay on the Panther system,
0.4% (10/2580) were positive for both CT and GC, 6.7% (172/2580) were positive for CT only, and 0.7% (18/2580) were positive for GC only.
Performance characteristics for detection of CT and GC in female urine samples were calculated separately (see Table 7 and Table 8).
Table 7: Performance of Aptima Combo 2 Assay on the Panther System Compared to Composite Comparator Algorithm Results for Detection of CT in Female Urine Samples
| Symptom
Status | n | CCA+
AC2+ | CCA-
AC2+ | CCA-
AC2- | CCA+
AC2- | PPA
(95% CI)2 | NPA
(95% CI)2 |
|-------------------|------|--------------|--------------|--------------|--------------|------------------|------------------|
| Symptomatic | 1379 | 109 | 23 | 12674 | 1 | 99.1 (95.0-99.8) | 99.8 (99.4-100) |
| Asymptomatic | 1193 | 65 | 35 | 11246 | 11 | 98.5 (91.9-99.7) | 99.7 (99.2-99.9) |
- = positive, - = negative, AC2 = Aptima Combo 2 assay on the Panther system, CCA = composite comparator algorithm, NPA= negative percent agreement, PPA= positive percent agreement
4 Includes equivocal results from Panther AC2 testing. Equivocal results from AC2 testing are considered indeterminate; a new specimen should be collected.
2 Score Confidence Interval
3 Of the 2 symptomatic subjects with CCA-negative results, both had positive CT vaginal swab sample results in both reference NAATs.
8
| Symptom
Status | n | CCA+
AC2+ | CCA-
AC2+ | CCA-
AC2- | CCA+
AC2- | PPA
(95% CI)2 | NPA
(95% CI)2 |
| ------------------- | --- | -------------- | -------------- | -------------- | -------------- | ------------------ | ------------------ |
|---|
4 Of the 1267 symptomatic subjects with CCA-negative results, 38 had at least one positive CT vaginal swab sample result by a reference NAAT; one or more vaginal swab sample reference results were not available for an additional 11 symptomatic subjects. The remaining 1218 symptomatic subjects had negative vaginal swab sample reference results.
5 Of the 3 asymptomatic subjects with CCA-negative results, 1 had positive CT vaginal swab sample results in both reference NAATs; the remaining 2 asymptomatic subjects had negative vaginal swab sample reference results.
6 Of the 1124 asymptomatic subjects with CCA-negative results, 20 had at least one positive CT vaginal swab sample result by a reference NAATs; one or more vaginal swab sample reference results were not available for an additional 11 asymptomatic subjects. The remaining 1093 asymptomatic subjects had negative vaginal swab sample reference results.
Table 8: Performance of Aptima Combo 2 Assay on the Panther System Compared to Composite Comparator Algorithm Results for Detection of GC in Female Urine Samples
| Symptom
Status | n | CCA+
AC2+ | CCA-
AC2+ | CCA-
AC2- | CCA+
AC2-1 | PPA
(95% CI)2 | NPA
(95% CI)2 |
|-------------------|------|--------------|--------------|--------------|---------------|------------------|------------------|
| Symptomatic | 1383 | 19 | 0 | 13633 | 1 | 95.0 (76.4-99.1) | 100 (99.7-100) |
| Asymptomatic | 1196 | 9 | 0 | 11874 | 0 | 100 (70.1-100) | 100 (99.7-100) |
- = positive. - = negative. AC2 = Aptima Combo 2 assay on the Panther system. CCA = composite comparator algorithm, NPA= negative percent agreement, PPA= positive percent agreement
1 Includes equivocal results from Panther AC2 testing. Equivocal results from AC2 testing are considered indeterminate; a new specimen should be collected.
2 Score Confidence Interval
3 Of the 1363 symptomatic subjects with TN (CCA-negative) results, 5 had at least one positive GC vaginal swab sample result by a reference NAATs; one or more reference results were not available for an additional 11 symptomatic subjects. The remaining 1347 symptomatic subjects had negative vaginal swab sample reference results.
4 Of the 1187 asymptomatic subjects with TN (CCA-negative) results, 6 had at least one positive GC vaginal swab sample result by a reference NAAT; one or more vaginal swab sample reference results were not available for an additional 11 asymptomatic subjects. The remaining 1170 asymptomatic subjects had negative vaginal swab sample reference results.
VIII. CONCLUSIONS
The clinical study results demonstrate that the Aptima Combo 2 assay on the Panther system is
substantially equivalent to the predicate device.
9
Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
10
Image /page/10/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue. The logos are simple and professional, and they are easily recognizable.
June 13, 2018
Hologic, Inc. Jeffrey Hergesheimer, MS, RAC Regulatory Affairs Manager 10210 Genetic Center Drive San Diego, California 92121
Re: K180681
Trade/Device Name: Aptima Combo 2 Assay (Panther System) Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ Dated: March 14, 2018 Received: March 15, 2018
Dear Jeffrey Hergesheimer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
11
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure