(293 days)
Not Found
No
The device description details a biochemical assay with signal amplification and a simple calculation for interpretation based on a fixed cutoff value. There is no mention of adaptive algorithms, learning from data, or complex pattern recognition characteristic of AI/ML.
No.
This device is an in-vitro diagnostic test used to detect the presence of C. trachomatis DNA, which aids in diagnosing an infection. It does not provide treatment or directly restore a lost function but rather provides information for diagnosis.
Yes
Explanation: The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the Digene HCII CT-ID Test is "indicated for use as an aid in diagnosing infection with C. trachomatis."
No
The device is an in-vitro diagnostic assay that involves physical reagents, specimen collection kits, and a luminometer, which are hardware components. While software is used for calculation and interpretation, the core of the device is a chemical and physical process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "in-vitro nucleic acid hybridization assay" and that it is used for the "qualitative detection of C trachomatis DNA in cervical specimens." This clearly indicates that the test is performed on biological samples taken from the body, outside of the body, to provide information about a medical condition (infection with C. trachomatis).
- Device Description: The description details the process of analyzing the specimen (denaturing DNA, hybridization with probes, capture on a microplate, detection with chemiluminescence) which is characteristic of an in-vitro diagnostic test.
- Performance Studies: The inclusion of performance studies comparing the device to other diagnostic methods (cell culture, DFA, PCR) further confirms its role as a diagnostic tool used in a laboratory setting.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help diagnose diseases or conditions. The Digene HCII CT-ID Test fits this definition perfectly.
N/A
Intended Use / Indications for Use
The Digene HCII CT-ID Test is an in-vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of C trachomatis DNA in cervical specimens collected using the Digene Cervical Sampler™ (Cervical Brush and Specimen Transport Medium) and in cervical specimens collected using the Digene Swab Specimen Collection Kit (Dacron Swab and Specimen Transport Medium). The Digene HCII CT-ID Test is indicated for use with symptomatic or asymptomatic women as evidence of infection with C. trachomatis. The HCII CT-ID Test may be used alone or as a supplemental test to the Digene HCII CT/GC Test to detect C. trachomatis DNA in specimens found positive by the Digene HCII CT/GC Test.
Product codes
LSK
Device Description
The Digene HCII CT-ID Test is a nucleic acid, signal enhanced, hybridization, microplate assay using chemiluminescence for the qualitative detection of C. trachomatis (CT) DNA in cervical specimens collected using the Digene Cervical Sampler™ and in cervical specimens collected with a Dacron swab and placed in Digene Specimen Transport Medium. The Digene HCII CT-ID Test is indicated for use as an aid in diagnosing infection with C. trachomatis in symptomatic or asymptomatic women. The HCII CT-ID Test may be used as a stand-alone test or may be used as a supplemental test to the Digene HCII CT/GC Test for identification of C. trachomatis in specimens that are positive by the HCII CT/GC Test.
Specimens potentially containing CT DNA are denatured and then hybridized with a specific RNA probe cocktail. This cocktail contains a probe mixture chosen to minimize or eliminate cross-reactivity with DNA sequences from human cells, other bacterial species, Chlamydia species other than trachomatis, or sequences from other operior misms common in urogenital specimens. The CT probe cocktail supplied with the Digene CT-ID Assay is complementary to approximately 39,300 base pairs or 4% of the C. trachomatis genome (1 x 10 base pairs) and 100% of the cryptic plasmid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical specimens
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
Not Found
Summary of Performance Studies
A multicenter study has demonstrated that the Digene HCII CT-ID Test performs as well or better than the gold standard, cell culture, in detecting infection with C. trachomatis in the intended population.
Study type: Multicenter study
Sample size: 940 (All sites combined for main study), 431 and 261 for other analyses, plus additional smaller groups for specific analyses (e.g., Dacron Swab Only)
Key results:
HCII CT-ID Test versus CT Culture/DF/:
- Overall (All sites, N=940): Prevalence 11.60%, Sensitivity 97.25% (92.2-99.4), Specificity 98.07% (96.9-98.9), NPV 99.63% (98.9-99.9), PPV 86.89% (79.6-92.3).
HCII CT-ID Test versus CT Culture/DFA (table 23-28): - Overall (All sites, N=431): Prevalence 5.10%, Sensitivity 100.00% (84.6-100), Specificity 98.29% (96.5-99.3), NPV 100% (99.1-100), PPV 75.86% (56.5-89.7).
HCII CT-ID Test versus CT Culture/DFA (table 35-39): - Overall (All sites, N=261): Prevalence 9.58%, Sensitivity 84.00% (63.9-95.5), Specificity 97.88% (95.1-99.3), NPV 98.30% (95.7-99.5), PPV 80.77% (60.7-93.5).
Asymptomatic Patients, Dacron Swab Only: - Overall (All sites, N=190): Prevalence 1.58%, Sensitivity 100.00% (29.2-100), Specificity 99.47% (97.1-100), NPV 100.00% (98.0-100), PPV 75.00% (19.4-99.4).
Key Metrics
Sensitivity, Specificity, NPV, PPV
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
OCT 2 5 1999
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: N/A - This is a new 510(k)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitter Digene Corporation 9000 Virginia Manor Road Beltsville, MD 20705
(301) 470-6500 Phone: Facsimile: (301) 470-2881
Contact Person Bryan Schneider, Regulatory Specialist Digene Corporation Phone: (301) 470-6573 Facsimile: (301) 470-2881
Date Prepared: 1/4/99
Name of Device and Name/Address of Sponsor
Name of Device Digene Hybrid Capture® II CT-ID Test
Sponsor Digene Corporation 9000 Virginia Manor Road Beltsville, MD 20705 Tel: (301) 470-6500 Fax: (301) 680-0696
Common or Usual Name
HCII CT-ID Test
A28-1
1
Classification Name
DNA Reagents, Chlamydia
Predicate Device(s)
The Gen-Probe Pace 2 System for Chlamydia Trachomatis cleared under K920378 on 4/29/92.
Device Description
The Digene HCII CT-ID Test is a nucleic acid, signal enhanced, hybridization, microplate assay using chemiluminescence for the qualitative detection of C. trachomatis (CT) DNA in cervical specimens collected using the Digene Cervical Sampler™ and in cervical specimens collected with a Dacron swab and placed in Digene Specimen Transport Medium. The Digene HCII CT-ID Test is indicated for use as an aid in diagnosing infection with C. trachomatis in symptomatic or asymptomatic women. The HCII CT-ID Test may be used as a stand-alone test or may be used as a supplemental test to the Digene HCII CT/GC Test for identification of C. trachomatis in specimens that are positive by the HCII CT/GC Test.
Specimens potentially containing CT DNA are denatured and then hybridized with a specific RNA probe cocktail. This cocktail contains a probe mixture chosen to minimize or eliminate cross-reactivity with DNA sequences from human cells, other bacterial species, Chlamydia species other than trachomatis, or sequences from other operior misms common in urogenital specimens. The CT probe cocktail supplied with the Digene CT-ID Assay is complementary to approximately 39,300 base pairs or 4% of the C. trachomatis genome (1 x 10 base pairs) and 100% of the cryptic plasmid.
Steps and Reagents to Stabilize the Specimen:
Specimens are collected using the Digene Cervical Sampler or a Dacron Swab and placed in Digene Specimen Transport Medium (STM). The specimens may be held for up to two weeks at room temperature and shipped without refrigeration to the testing laboratory in an insolated container using an overnight or 2-day delivery vendor. At the testing laboratory specimens should be stored at 2-8℃ if the assay is to be performed within one week. If the assay will be performed later than one week, the specimens should be stored at -20°C. A preservative has been added to the STM to retard bacterial growth and retain the integrity of DNA in the specimen. The STM is not intended to preserve the viability of organisms or other cells in the specimen.
Steps to Process the Specimen, Release the DNA, and Denature the Released DNA.
Denaturation reagent is added to the specimens with the collection device remaining in the collection tube. This allows for denaturation of any DNA clinging to the collection device. The volume of denaturation reagent added to the specimen is equivalent to one-half the volume of the specimen. The denaturation reagent is dilute sodium hydroxide. Specimens are then incubated for 45 minutes at 65°C. This step releases the DNA from the organisms contained in the specimen and denatures that DNA so it becomes single-stranded. Following this step, the single-stranded DNA is ready to be hybridized to the RNA probe.
1 Kingsbury DT. Estimate of the genome size of various microorganisms. J Bacteriol 1969 Jun:98(3):1400-1.
2
The RNA:DNA hybrids resulting from hybridization are immobilized (captured) on the surface of a microplate-well, which has been coated with antibodies specific for RNA:DNA hybrids. The antibodies on the well surface capture the RNA:DNA hybrids. The immobilized hybrids are then reacted with alkaline phosphatase-conjugated antibody and a chemiluminescent substrate. As the substrate is cleaved by the bound alkaline phosphatase, photons are emitted and measured as Relative Light Units (RLUs) using a standard, FDA-cleared luminometer such as the DML 2000™ - Increased photon emission, resulting in an enhanced signal, is achieved by conjugating multiple alkaline phosphatase molecules to each antibody molecule. Multiple antibodies bind to each RNA:DNA hybrid, further enhancing the signal.
The HCII CT-ID Test provides an RLU measurement that is qualitatively interpreted. The Positive Cutoff Value is equal to the mean of three Positive Control values. Each specimen RLU measurement is converted to a ratio of the Positive Cutoff Value. This conversion calculation is performed automatically by the Digene DML™ 2000 Microplate Luminometer software. Alternatively, the conversion may be calculated manually, Specimens with RLU/Cutoff values of 5.0 are considered positive for CT DNA. Specimens with RLU/Cutoff values between 0.8 ≥ 5.0 are considered to be equivocal and are repeat tested in duplicate. With the repeat tests, a RLU/Cutoff Value of 1.0 is applied. If two of the three replicates fall above 1.0, the presence of C. trachomatis DNA is indicated. If at least two of the three replicates fall below 1.0, the presence of C. trachomatis DNA is not indicated.
Intended Use
The Digene HCII CT-ID Test, is a nucleic acid, signal enhanced, hybridization, microplate assay for the qualitative detection of C. trachomatis DNA in cervical specimens collected using the Digene Cervical Sampler™, or collected using a Dacron® swab and placed in Digene Specimen Transport Medium. The Digene HCII CT-ID Test is indicated for use as an aid in diagnosing infection with C. trachomatis in symptomatic or asymptomatic females. The HCII CT-ID Test may be used as a stand-alone test or may be used as a supplemental test for identification of C. trachomatis in specimens found positive by the Digene HCII CT/GC Test.
Technological Characteristics and Substantial Equivalence
The Digene HCll CT-ID Test is substantially equivalent to the Gen-Probe Pace 2 System for C. trachomatis in intended use and in technological characteristics. Both tests are nucleic acid hybridization assays intended for the detection of chlamydia trachomatis from endocervical specimens.
A multicenter study has demonstrated that the Digene HCII CT-ID Test performs as well or better than the gold standard, cell culture, in detecting infection with C. trachomatis in the intended population. The results from this multicenter study are summarized below:
3
HCll CT-ID Test versus CT Culture/DF/
| CT-ID | | | Culture | | | DFA:
NA | N | Site | 2x2 Table
Reference | Prevalence
(%) | Sensitivity
(95% CI) | Specificity
(95% CI) | Ct-ID+/Cul-
/DFA-
Tested Positive
by PCR | NPV
(95% CI) | PPV
(95% CI) |
|-------|-----|------------|---------|-----|------------------|------------|-----|------|------------------------|-------------------|-------------------------|-------------------------|---------------------------------------------------|----------------------|----------------------|
| POS | NEG | POS
NEG | POS | NEG | POS
NEG
NA | | | | | | | | | | |
| | | | | | | | 351 | UAB | 18 | 13.96 | 95.92
(86.0-99.5) | 97.68
(95.3-99.1) | 5/7 | 99.33
(97.6-99.9) | 87.04
(75.1-94.6) |
| | | | | | | | 192 | JHU | 19 | 8.33 | 100.00
(79.4-100) | 96.59
(92.7-98.7) | 6/6 | 100.00
(97.9-100) | 72.73
(49.8-89.3) |
| | | | | | | | 220 | SUNY | 20 | 15.91 | 97.14
(85.1-99.3) | 98.38
(95.3-99.7) | 1/2 | 99.45
(97.0-100) | 91.89
(78.1-98.3) |
| | | | | | | | 177 | UCSF | 21 | 5.08 | 100.00
(66.4-100) | 100.00
(97.8-100) | NA | 100.00
(97.8-100) | 100.00
(66.4-100) |
| | | | | | | | 940 | All | 22 | 11.60 | 97.25
(92.2-99.4) | 98.07
(96.9-98.9) | 12/15 | 99.63
(98.9-99.9) | 86.89
(79.6-92.3) |
DO NOT DELAY - FILE IMMEDIATELY
NICS WAS TERMINATED
7/1/2021
ONE FORM PER TRANSACTION
- One CT-ID negative, culture negative specimen was unnecessarily tested by DFA and gave a positive result. This result was included in the pen
calculations as a HCILCT-ID false negative.
ce
t hwc case, DFA was required with in the love a positive sest. The patim andred in its perfornance
all chil negative, ciller negative by clime and negative by DFA. The t
4
| x2 Table
Reference | Site | CT-ID:
Culture: | DFA:
N | POS
POS
NA | POS
NEG
POS | POS
NEG
NEG | NEG
POS
NA | NEG
NEG
POS | NEG
NEG
NEG | Prevalence
(%) | Sensitivity
(95% CI) | Specificity
(95% CI) | Ct-ID+/Cul-
/DFA-
Tested Positive
by PCR | NPV
(95% CI) | PPV
(95% CI) |
|------------------------|------|--------------------|------------|------------------|-------------------|-------------------|------------------|-------------------|-------------------|-------------------------|-------------------------|---------------------------------------------------|---------------------------------------------------|----------------------|----------------------|
| 23 | UAB | 101 | 8 | 0 | 2 | 0 | NA | 91 | | 7.92 | 100.00
(63.1-100) | 97.85
(92.5-99.7) | 0/2 | 100.00
(96.0-100) | 80.00
(44.4-97.5) |
| 24 | JHU | 12 | 1 | 0 | 1 | 0 | NA | 10 | | 8.33 | 100.00
(2.50-100) | 90.91
(58.7-99.8) | 1/1 | 100.00
(69.2-100) | 50.00
(1.3-98.7) |
| 25 | SUNY | 81 | 3 | 0 | 0 | 0 | NA | 78 | | 3.70 | 100.00
(29.2-100) | 100.00
(95.4-100) | NA | 100.00
(95.4-100) | 100.00
(29.2-100) |
| 26 | UCSF | 236 | 9 | 1 | 4 | 0 | NA | 222 | | 4.24 | 100.00
(69.2-100) | 98.23
(95.5-99.5) | 3*/4 | 100.00
(98.4-100) | 71.43
(41.9-91.6) |
| 27 | SJH | 1 | 0 | 0 | 0 | 0 | NA | 1 | | 0 | N/A | 100.00
(2.5-100) | | 100.00
(2.5-100) | N/A |
| 28 | All | 431 | 21 | 1 | 7 | 0 | NA | 402 | | 5.10 | 100.00
(84.6-100) | 98.29
(96.5-99.3) | 4*/7 | 100
(99.1-100) | 75.86
(56.5-89.7) |
| | | | CT-ID: | | | | | | | | | | | | |
| | | | Culture: | | | | | | | | | | | | |
| | | | DFA: | | | | | | | | | | | | |
| 2x2 Table
Reference | Site | N | POS
POS | POS
NEG | POS
NA | NEG
POS | NEG
NEG | NEG
NA | Prevalence
(%) | Sensitivity
(95% CI) | Specificity
(95% CI) | Ct-ID+/Cul-
/DFA-
Tested Positive by
PCR | NPV
(95% CI) | PPV
(95% CI) | |
| 35 | UAB | 7 | 2 | 0 | 0 | 1 | 4 | NA | 42.86 | 66.67
(94.3-99.2) | 100
(39.8-100) | N/A | 80.00
(28.4-99.5) | 100.00
(15.8-100) | |
| 36 | JHU | 94 | 10 | 1 | 3 | 1 | 79 | NA | 12.77 | 91.67
(61.5-99.8) | 96.34
(89.6-99.2) | 2/3 | 98.75
(93.2-99.9) | 78.57
(49.2-95.3) | |
| 37 | SUNY | 8 | 1 | 0 | 0 | 2 | 5 | NA | 37.50 | 33.33
(0.84-90.6) | 100.00
(47.8-100) | N/A | 71.43
(29.0-96.3) | 100.00
(2.5-100) | |
| 38 | SJH | 152 | 7 | 0 | 2 | 0 | 143 | NA | 4.61 | 100.00
(59.0-100) | 98.62
(95.1-99.8) | 0/1 | 100.00
(97.5-100) | 77.78
(40.0-97.2) | |
| 39 | All | 261 | 20 | 1 | 5 | 4 | 231 | NA | 9.58 | 84.00
(63.9-95.5) | 97.88
(95.1-99.3) | 2/4 | 98.30
(95.7-99.5) | 80.77
(60.7-93.5) | |
- Bone case, PCR was not done.
5
HCli CT-ID Test versus CT Culture/DFA
In one case DFA was required but not done.
In one case, PCR was not done.
6
| HCII CT-ID Test versus CT Culture/DFA |
|---|
| Asymptomatic Patients |
| Dacron Swab Only |
| CT-ID: | POS | POS | POS | NEG | NEG | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Culture: | POS | NEG | NEG | POS | NEG | ||||||||
| x2 Table | |||||||||||||
| Reference | Site | DFA: | |||||||||||
| N | POS | NEG | POS | NEG | NEG | Prevalence | |||||||
| (%) | Sensitivity | ||||||||||||
| (95% CI) | Specificity | ||||||||||||
| (95% CI) | CI-ID+CuHDFA- | ||||||||||||
| Tested Positive by | |||||||||||||
| PCR | NPV | ||||||||||||
| (95% CI) | PPV | ||||||||||||
| (95% CI) | |||||||||||||
| 40 | UAB | 1 | 1 | 0 | 0 | 0 | 0 | 100 | 100 | ||||
| (2.5-100) | NA | N/A | NA | 100.00 | |||||||||
| (2.5-100) | |||||||||||||
| 41 | JHU | 10 | 0 | 0 | 0 | 0 | 10 | 0.0 | NA | 100 | |||
| (69.2-100) | N/A | 100.00 | |||||||||||
| (69.2-100) | NA | ||||||||||||
| 42 | SUNY | 2 | 0 | 0 | 1 | 0 | 1 | 0.0 | NA | 50.00 | |||
| (1.3-98.7) | N/A | 100.00 | |||||||||||
| (2.5-100) | 0.00 | ||||||||||||
| (0-97.5) | |||||||||||||
| 43 | UCSF | 1 | 0 | 0 | 0 | 0 | 1 | 0.0 | NA | 100 | |||
| (2.5-100) | N/A | 100.00 | |||||||||||
| (2.5-100) | NA | ||||||||||||
| 44 | SJH | 176 | 2 | 0 | 0 | 0 | 174 | 1.14 | 100.00 | ||||
| (15.8-100) | 100.00 | ||||||||||||
| (97.9-100) | N/A | 100.00 | |||||||||||
| (97.9-100) | 100.00 | ||||||||||||
| (15.8-100) | |||||||||||||
| 45 | All | 190 | 3 | 0 | 1 | 0 | 186 | 1.58 | 100.00 | ||||
| (29.2-100) | 99.47 | ||||||||||||
| (97.1-100) | N/A | 100.00 | |||||||||||
| (98.0-100) | 75.00 | ||||||||||||
| (19.4-99.4) |
CT/GC+/Cul- = specimens positive by Hybrid Cres and negative by CH. The data represented in this table are
unresolved. The PCR data is provided for informational proses onl
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.
OCT 2 5 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark A. Del Vecchio Associate Director, Regulatory and Clinical Affairs Digene Corpration 9000 Virginia Manor Road Rockville, Maryland 20705
Re: K990023 Trade Name: Digene HCII CT-ID Test Regulatory Class: I Product Code: LSK Dated: August 16, 1999 Received: August 17, 1999
Dear Mr. Del Vecchio:
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 (OS) 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.
8
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device Onder the Omical Baoordexity categorization. To determine if it ides, you should contact a 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) I mis reter will anow Jour of Substantial equivalence of your device 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 Compliance at (301) 5947 price, 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 Autman
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
9
Page_I_of_I
510(k) Number (if known):_K 99 co 2 3 Device Name: Digene HC II CT - ID
Device Name: Digene's HC II CT -
Indications For Use:
The Digene HCII CT-ID Test is an in-vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of C trachomatis DNA in cervical specimens collected using the Digene Cervical Sampler™ (Cervical Brush and Speciment Transport Medium) and in cervical Sampler™
using the Digene Swah Speciment Collection (Aind) specimens collected using the Digene Swab Specimen Collection Kit (Dacron) Swab Specimens Collected
Transport Medium) The Digene Transport Medium). The Digene HCII Onlietion Swab and Speciment
or asymptomatic women as evidence of infrastian with CT-ID Test is indicated for use with symptomatic or used to be and the Digene Holl CT4D Test is indicated for use
The HCII CT-ID Test may be used alone or as a supplemental test to the Digene HCII CT/GC Test to detect C. trachomatis Dras a Supplemental test to the Digene HCll
CT/GC Test. CT/GC Test.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wooley Dubois
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K990023
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)