(881 days)
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No
The summary describes a molecular diagnostic assay based on Ligase Chain Reaction (LCR) technology for detecting Neisseria gonorrhoeae. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance evaluation is based on comparison to traditional culture methods.
No
The device is described as an assay for the qualitative detection of a specific nucleic acid sequence, meaning it is a diagnostic tool, not a therapeutic one.
Yes
The device is used for the "qualitative detection of a specific target nucleic acid sequence... of Neisseria gonorrhoeae," which is a diagnostic test for the presence of the bacteria.
No
The device description explicitly states it uses "LCR™ (Ligase Chain Reaction) amplification technology in the LCx Probe System," which are hardware components used for molecular diagnostics.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "direct, qualitative detection of a specific target nucleic acid sequence in the Opa gene of Neisseria gonorrhoeae in female endocervical and male urethral swab specimens or in male and female urine specimens". This describes a test performed on samples taken from the human body to provide information about a disease state (presence of Neisseria gonorrhoeae).
- Device Description: The description details the technology used (LCR amplification) for the "direct, qualitative detection" of a target in Neisseria gonorrhoeae. This further confirms it's a test performed on biological samples.
- Performance Studies: The performance studies describe comparing the assay results to culture, which is a standard method for diagnosing Neisseria gonorrhoeae infection. This demonstrates the device is intended for diagnostic purposes.
- Key Metrics: The key metrics listed (Sensitivity and Specificity) are standard performance measures for diagnostic tests.
All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The LCx Neisseria gonorrhoeae Assay uses LCR™ (Ligase Chain Reaction) amplification technology in the LCx Probe System for the direct, qualitative detection of a specific target nucleic acid sequence in the Opa gene of Neisseria gonorrhoeae in female endocervical and male urethral swab specimens or in male and female ur ne specimens from symptomatic and asymptomatic males and females.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The LCx Neisseria gonorrhoeae Assay uses LCR™ (Ligase Chain Reaction) amplification technology in the LCx Probe System for the direct, qualitative detection of a specific target nucleic acid sequence in the Opa gene of Neisseria gonorrhoeae.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
female endocervical, male urethral, female urine, male urine specimens
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics of the LCx Neisseria gonorrhoeae Assay were determined by comparing assay results to results of culture for Neisseria gonorrhoeae in four U.S. sites. Studies included both fresh and frozen specimens.
Sample sizes for fresh specimens comparison to culture:
Female Endocervical: 623 asymptomatic, 332 symptomatic
Female Urine: 140 asymptomatic, 237 symptomatic
Male Urethra: 172 asymptomatic, 412 symptomatic
Male Urine: 234 asymptomatic, 466 symptomatic
Total: 1169 asymptomatic, 1447 symptomatic
Sample sizes for frozen specimens comparison to culture:
Female Endocervical: 78 asymptomatic, 112 symptomatic
Female Urine: 74 asymptomatic, 129 symptomatic
Male Urethra: 74 asymptomatic, 92 symptomatic
Male Urine: 74 asymptomatic, 93 symptomatic
Total: 300 asymptomatic, 446 symptomatic
Analytical sensitivity (limit of detection) is 10 Colony Forming Units (CFU) of any of the 6 auxotrophs of Neisseria gonorrhoeae. Determined by serial dilution study on all 6 auxotrophs (auxotype 1, 5, 9, 12, 16, and 23) of Neisseria gonorrhoeae. Each auxotroph diluted to less than 10 CFU per reaction and tested. All replicates of dilutions giving 10 CFU per test were positive.
Specificity was evaluated against 91 bacteria, parasites, viruses, yeast and fungi, including common urogenital tract organisms and 12 non-gonococcal Neisseria species. All gave negative results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance Summary Compared to Culture: Frozen Specimens
| Sample Type | Symptomatology | Sensitivity
(95% C.I.) | Specificity
(95% C. I.) |
|---------------------|----------------|----------------------------------|----------------------------|
| Female Endocervical | Asymptomatic | 88.9% (24/27)
(70.8-97.6) | 98.2% (505/596)
(96.7-99.1) |
| | Symptomatic | 100.0% (47/47)
(92.5-100.0) | 97.2% (277/285)
(94.5-98.8) |
| Female Urine | Asymptomatic | 92.0% (23/25)
(74.0-99.0) | 99.1% (114/115)
(95.3-100.0) |
| | Symptomatic | 95.6% (43/45)
(84.5-99.5) | 100.0% (192/192)
(98.1-100.0) |
| Male Urethra | Asymptomatic | 85.7% (6/7)
(42.1-99.6) | 98.8% (163/165)
(95.7-99.9) |
| | Symptomatic | 98.7% (155/157)
(95.5-99.2) | 97.6% (249/255)
(94.9-99.1) |
| Male Urine | Asymptomatic | 85.7% (6/7)
(42.1-99.6) | 99.6% (226/227)
(97.5-100.0) |
| | Symptomatic | 99.4% (170/171)
(96.8-100.0) | 96.6% (285/295)
(93.5-98.4) |
| Total | Asymptomatic | 89.4% (59/66) | 98.6% (1088/1103) |
| | Symptomatic | 98.8% (415/420) | 97.7% (1003/1027) |
Performance Summary Compared to Culture: Fresh Specimens
| Sample Type | Symptomatology | Sensitivity
(95% C.I.) | Specificity
(95% C.I.) |
|---------------------|----------------|--------------------------------|---------------------------------|
| Female Endocervical | Asymptomatic | 100.0% (10/10)
(69.2-100.0) | 95.6% (65/68)
(87.6-99.1) |
| | Symptomatic | 100.0% (20/20)
(83.2-100.0) | 99.1% (111/112)
(95.1-100.0) |
| Female Urine | Asymptomatic | 100.0% (9/9)
(66.4-100.0) | 98.5% (64/65)
(91.7-100.0) |
| | Symptomatic | 85.0% (17/20)
(62.1-96.8) | 99.1% (108/109)
(95.0-100.0) |
| Male Urethra | Asymptomatic | 100.0% (1/1)
(2.5-100.0) | 100.0% (73/73)
(95.1-100.0) |
| | Symptomatic | 100.0% (47/47)
(92.5-100.0) | 97.8% (44/45)
(88.2-99.9) |
| Male Urine | Asymptomatic | 100.0% (1/1)
(2.5-100.0) | 100.0% (73/73)
(95.1-100.0) |
| | Symptomatic | 97.9% (47/48)
(88.9-99.9) | 97.8% (44/45)
(86.2-99.9) |
| Total | Asymptomatic | 100.0% (21/21) | 98.6% (275/279) |
| | Symptomatic | 97.0% (131/135) | 98.7% (307/311) |
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
MAY -6 1996
LCx® Neisseria gonorrhorae Assay
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIAL EQUIVALENCE DETERMINATION
The following information as presented in the Premarket Notification (510(k) for LCx Neisseria gonorrhoeae Assay) constitutes data supporting a substantially equivalent determination.
The LCx Neisseria gonorrhoeae Assay uses LCR™ (Ligase Chain Reaction) amplification technology in the LCx Probe System for the direct, qualitative detection of a specific target nucleic acid sequence in the Opa gene of Neisseria gonorrhoeae in female endocervical and male urethral swab specimens or in male and female ur ne specimens from symptomatic and asymptomatic males and females.
The LCx Neisseria gonorrhoeae Assay is substantially iquivalent to the culture method.
The two methods are similar in that:
-Both assays detect the presence of N. gonorrhoeae.
-Both assays are in vitro tests.
The two methods differ in that:
-The LCx Neisseria gonorrhoeae Assay detects the DNA of N. gonorrhoeae
organisms, while the culture method detects the whole organism.
-The LCx Neisseria gonorrhoeae Assay detects the DNA of N. gonorrhoeae in male and female urine.
In four U.S. sites, the performance characteristics of the LCx Neisseria gonorrhoeae Assay were determined by comparing assay results to results of culture for Neisseria gonorrhoeae. The overall results presented by specimen type and storage condition are shown in the table below.
| Sample Type | Symptomatology | Total | LCx
Culture | Pos
Pos | Pos
Neg | Neg
Pos | Neg
Neg | Sensitivity
(95% C.I.) | Specificity
(95% C. I.) |
|---------------------|----------------|-------|----------------|------------|------------|------------|---------------------------------|----------------------------------|----------------------------|
| Female Endocervical | Asymptomatic | 623 | 24 | 11 | 3 | 585 | 88.9% (24/27)
(70.8-97.6) | 98.2% (505/596)
(96.7-99.1) | |
| | Symptomatic | 332 | 47 | 8 | 0 | 277 | 100.0% (47/47)
(92.5-100.0) | 97.2% (277/285)
(94.5-98.8) | |
| Female Urine | Asymptomatic | 140 | 23 | 1 | 2 | 114 | 92.0% (23/25)
(74.0-99.0) | 99.1% (114/115)
(95.3-100.0) | |
| | Symptomatic | 237 | 43 | 0 | 2 | 192 | 95.6% (43/45)
(84.5-99.5) | 100.0% (192/192)
(98.1-100.0) | |
| Male Urethra | Asymptomatic | 172 | 6 | 2 | 1 | 163 | 85.7% (6/7)
(42.1-99.6) | 98.8% (163/165)
(95.7-99.9) | |
| | Symptomatic | 412 | 155 | 6 | 2 | 249 | 98.7% (155/157)
(95.5-99.2) | 97.6% (249/255)
(94.9-99.1) | |
| Male Urine | Asymptomatic | 234 | 6 | 1 | 1 | 226 | 85.7% (6/7)
(42.1-99.6) | 99.6% (226/227)
(97.5-100.0) | |
| | Symptomatic | 466 | 170 | 10 | 1 | 265 | 99.4% (170/171)
(96.8-100.0) | 96.6% (285/295)
(93.5-98.4) | |
| Total | Asymptomatic | 1169 | 59 | 15 | 7 | 1088 | 89.4% (59/66) | 98.6% (1088/1103) | |
| | Symptomatic | 1447 | 415 | 24 | 5 | 1003 | 98.8% (415/420) | 97.7% (1003/1027) | |
Performance Summary Compared to Culture: Frozen Specimens
1
| Sample Type | Symptomatology | Total | LCx
Culture | Pos
Pos | Pos
Neg | Neg
Neg | Sensitivity
(95% C.I.) | Specificity
(95% C.I.) |
|---------------------|----------------|-------|----------------|------------|------------|------------|--------------------------------|---------------------------------|
| Female Endocervical | Asymptomatic | 78 | 10 | 3 | 0 | 55 | 100.0% (10/10)
(69.2-100.0) | 95.6% (65/68)
(87.6-99.1) |
| | Symptomatic | 112 | 20 | 1 | 0 | 111 | 100.0% (20/20)
(83.2-100.0) | 99.1% (111/112)
(95.1-100.0) |
| Female Urine | Asymptomatic | 74 | 9 | 1 | 0 | 64 | 100.0% (9/9)
(66.4-100.0) | 98.5% (64/65)
(91.7-100.0) |
| | Symptomatic | 129 | 17 | 1 | 3 | 108 | 85.0% (17/20)
(62.1-96.8) | 99.1% (108/109)
(95.0-100.0) |
| Male Urethra | Asymptomatic | 74 | 1 | 0 | 0 | 73 | 100.0% (1/1)
(2.5-100.0) | 100.0% (73/73)
(95.1-100.0) |
| | Symptomatic | 92 | 47 | 1 | 0 | 44 | 100.0% (47/47)
(92.5-100.0) | 97.8% (44/45)
(88.2-99.9) |
| Male Urine | Asymptomatic | 74 | 1 | 0 | 0 | 73 | 100.0% (1/1)
(2.5-100.0) | 100.0% (73/73)
(95.1-100.0) |
| | Symptomatic | 93 | 47 | 1 | 1 | 44 | 97.9% (47/48)
(88.9-99.9) | 97.8% (44/45)
(86.2-99.9) |
| Total | Asymptomatic | 300 | 21 | 4 | 0 | 275 | 100.0% (21/21) | 98.6% (275/279) |
| | Symptomatic | 446 | 131 | 4 | 4 | 307 | 97.0% (131/135) | 98.7% (307/311) |
Performance Summary Compared to Culture: Fresh Specimens
The analytical sensitivity of this assay (limit of detection) is 10 Colony Forming Units (CFU) of any of the 6 auxotrophs of Neisseria gonorrhoeae. The analytical sensitivity of this assay was determined by a serial dilution study on all 6 auxotrophs (auxotype 1, 5, 9, 12, 16, and 23) of Neisseria gonorrhoeae. Each auxotroph was diluted to less than 10 CFU per reaction and tested in the LCx Neisseria gonorrhoeae Assay. In all cases, each replicate of a dilution giving 10 CFU per test (100 ul specimen volume) was positive by the LCx Neisseria gonorrhoeae Assay.
91 bacteria, parasites, viruses, veast and fungi, including organisms that are commonly found in the urogenital tract and 12 non-gonococcal Neisseria species were tested by the LCx Neisseria gonorrhoeae Assay. All gave negative results indicating the specificity of the test.
In conclusion the LCx Neisseria gonorrhoeae Assay is substantially equivalent to culture for detection of Neisseria gonorrhoeae in endocervical, male urethral, female and male urine specimens.
Prepared and submitted April 1, 1996 Mary Spiewak 847-937-5376 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537