(194 days)
No
The device description and performance studies focus on standard laboratory automation and PCR processes, with no mention of AI or ML algorithms for analysis or decision-making.
No.
The device is an in vitro diagnostic device used in clinical laboratories for the automation of PCR test procedures, not for treating patients.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The COBAS AMPLICOR Analyzer is an in vitro diagnostic device".
No
The device description explicitly lists multiple hardware components (thermal cycler, pipeting station, incubation station, wash station, photometer) that are integral to the device's function. While it mentions an internal computer for control, the device is clearly a physical instrument with automated processes.
Yes, the COBAS AMPLICOR Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "in vitro diagnostic device intended for use in clinical laboratories for the automation of the AMPLICOR™ Polymerase Chain Reaction test procedures." This is the most direct confirmation.
- Function: The device automates steps of the Polymerase Chain Reaction (PCR) process, which is a common technique used in in vitro diagnostics to detect and amplify genetic material from biological samples.
- Clinical Setting: It is intended for use in "clinical laboratories," which are the typical settings for performing in vitro diagnostic tests.
- Specimen Types: It is used with "female endocervical, male urethral, and male urine specimens," which are biological samples collected from patients for diagnostic purposes.
- Performance Studies: The document includes "Clinical Performance" studies comparing the device's performance to a predicate device using clinical specimens, which is a requirement for demonstrating the diagnostic utility of an IVD.
All these points align with the definition and characteristics of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COBAS AMPLICOR is an in vitro diagnostic device intended for use in the amplification and detection steps of the Polymerase Chain Reaction (PCR) process.
The COBAS AMPLICOR Analyzer is an in vitro diagnostic device intended for use in clinical laboratories for the automation of the AMPLICOR™ Polymerase Chain Reaction test procedures.
Product codes
JJF
Device Description
The COBAS AMPLICOR is a flexible, automated bench top batch analyzer that automates the amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The COBAS AMPLICOR combines the operations of automated sample handling, reagents deliver, thermal cycling, controlled temperature incubation, photometric detection and result reporting into a single automated analyzer. The instrument consists of five major sub-components: (1) a thermal cycler module; (2) an automated pipeting station; (3) an incubation station; (4) a wash station; and (5) a photometer. An internal computer controls and monitors the major components includingsystem and run control, input/output, communication, results calculaton, and system diagnostic tests.
Specimens are prepared off-line with AMPLICOR Specimen Preparation reagents before being transferred to amplification tubes (A-tubes) placed on the analyzer. Twelve A-tubes with caps are provided as a molded assembly called an A-ring. The COBAS AMPLICOR automatically performs test specific thermal cycling operations for PCR amplification. Amplified product is automatically transferred to polystyrene specimen cups (D cups) and primer coated magnetic beads are added. Following incubation, unbound material is removed by serial wash steps. Hybridized amplicon is measured by a enzymatically catalyzed color reaction. The intensity of the color is proportional to the amount of infectious organisms present in the specimen and qualitative results are determined based on a specified absorbance cut-off.
The amplification and detection operations can be run in parallel or sequentially depending on the number of samples in the run and user preference. In sequential mode, the analyzer automatically proceeds to sample detection after amplification, and the pipettor transfers amplified products from the A-ring in the thermal cycling segments to the D-cups for hybridization, wash and detection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Female endocervical, male urethral, and male urine 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance:
Precision: A multi-operator study was performed to determine the reproducibility of the COBAS AMPLICOR Chlamydia trachomatis Test. The study design was based upon the study suggested in the NCCLS document EP5-T2. Three independent operators tested a series of samples once a day for three days. A test run consisted of the amplification and detection of the following samples in triplicate: COBAS AMPLICOR Chlamydia trachomatis Test CT (+) and CT (-) kit controls and specimens that were prepared by spiking AMPLICOR Specimen Transport Medium with infected McCoy cell suspensions to obtain levels of 0, 1, 10 and 50 C. trachomatis IFUIPCR. Calculations were performed using the Analysis of Variance model suggested in the NCCLS document to derive estimates of between-day, between-operator, within-operator, and total variance for the Test at each sample concentration. Results are presented in Table 2.
Clinical Performance:
Study Type: Comparative Clinical Performance Study
Sample Size: 639 clinical specimens (266 endocervical swabs, 93 male urethral swabs, and 280 male urine specimens)
Key Results: The clinical data reported were obtained using the AMPLICOR Chlamydia trachomatis Test. The AMPLICOR microwell assay and the COBAS AMPLICOR Chlamydia trachomatis Test procedures are highly conserved and differ only in the method of detection. The COBAS AMPLICOR utilizes a magnetic microparticle based solid support compared to microwell plates and the automated analyzer enables the elimination of an endpoint hydrolysis Stop reagent that changes the absorbance maximum of the chromophore. The COBAS AMPLICOR and AMPLICOR Tests use the exact same specimen preparation, detection and amplification reagents, including identical amplification primer (CP24 and CP27) and detection probe (CP35) sequences. Therefore, equivalent clinical performance is expected from the microwell and automated COBAS Tests.
To ensure that equivalent clinical performance of the COBAS AMPLICOR Chiamydia trachomatis Test and the AMPLICOR Chlamydia Trachomatis Test are obtained, a comparison of the two test procedures was performed in which 639 clinical specimens were tested. The specimens included 266 endocervical swabs, 93 male urethral swabs, and 280 male urine specimens. Table 3 shows the comparative clinical performance obtained when these specimens were tested by the two test procedures. The results for each specimen type were evaluated for statistical difference in comparative clinical performance using McNemar's Test. For each of the three specimen types tested, the McNemar's Test found a value of P > 0.4. This finding provides strong evidence that there are no differences in the positive and negative results obtained when testing these specimens by either the COBAS AMPLICOR Chlamydia Trachomatis Test or the AMPLICOR Chlamydia Trachomatis Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision metrics: Mean Absorbance, Minimum, Maximum, Between Day Variance, Standard Deviation, CV (%), Between Operator Variance, Within Operator Variance, Total Variance. (Values are listed in Table 2)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
K964506 MAY
21 1997
Roche Molecular Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876
510(k) Summary
COBAS AMPLICOR™ Analyzer
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
Identification of 510(k) Sponsor: I.
Roche Molecular Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-1760
Roche Molacular Syste
subsidiary of Hoffmann-La Roche
510(k) submission dated November, 1996
- Contact: Alex Wesolowski Telephone: (908) 253-7540 Facsimile: (908) 253-7547
II. Device Name:
COBAS AMPLICOR™ Analyzer Trade/Proprietary Name -Automated batch analyzer for nucleic acid amplification Common or Usual Name and detection
None applicable Classification Name -
Identification of legally marketed device to which the 510(k) sponsor claims III. equivalence:
The primary operational components of the COBAS AMPLICOR analyzer are the pipettor, thermal cycler, wash stations, and the photometric detection system. As independent components, each is categorized as Class I devices under 21 CFR 862 (Table 1). The COBAS AMPLICOR combines these operational functions into a single automated instrument that provides an interpretative qualitative result. The performance of the COBAS AMPLICOR is substantially equivalent to several currently marketed device used independently to perform the same functions.
1
| Predicate Device | Regulatory Class | Classification
Number . | Predicate Product
Name | Predicate
510(k)
Number |
|--------------------------------|------------------|----------------------------|---------------------------------------------------------------------------------|-------------------------------|
| Automated Pipettor | Class 1 | 862.2750 | Matrix Technologies
Impact Pipettor | K940390 |
| Thermal cycler (incubator) | Class I exempt | 862.2750 | Perkin-Elmer 9600
Thermal cycler | NA |
| Incubator | Class I exempt | 862.2050 | Fisher Dry Heat
Incubator Model 630D | NA |
| Automated Microplate
Washer | Class 1 exempt | 866.2500 | Bio-Tek Instruments
Automated Microplate
Washer Model Model
ELP40 | NA |
| Automated Microplate
Reader | Class 1 | 862.2300 | Bio-Tek Instruments
Auomated EAI
Microplate Reader
Models Elx800/EL800 | K950104 |
TABLE 1 Predicate Devices for the COBAS AMPLICOR Analyzer
The COBAS AMPLICOR analyzer is designed for exclusive use with COBAS AMPLICOR The Roche AMPLICOR Chlamydia trachomatis Test (microwell plate) and the reagents. COBAS AMPLICOR Chlamydia trachomatis Test are both intended for the qualitative determination of Chlamydia trachomatis plasmid DNA in female endocervical, male urethral, and male urine specimens from symptomatic and asymptomatic patients. The Roche COBAS AMPLICOR Chlamydia trachomatis Test performed on the Roche COBAS AMPLICOR analyzer is substantially equivalent to the Roche AMPLICOR Chlamydia trachomatis Test (K922906/C, June 15,1993) performed on the Perkin-Elmer 9600 thermal cycler and the Bio-Tek EL800 (K950104) microtiter plate reader.
IV. Description of the Device:
The COBAS AMPLICOR is a flexible, automated bench top batch analyzer that automates the amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The COBAS AMPLICOR combines the operations of automated sample handling, reagents deliver, thermal cycling, controlled temperature incubation, photometric detection and result reporting into a single automated analyzer. The instrument consists of five major sub-components: (1) a thermal cycler module; (2) an automated pipeting station; (3) an incubation station; (4) a wash station; and (5) a photometer. An internal computer controls and monitors the major components includingsystem and run control, input/output, communication, results calculaton, and system diagnostic tests.
Specimens are prepared off-line with AMPLICOR Specimen Preparation reagents before being transferred to amplification tubes (A-tubes) placed on the analyzer. Twelve A-tubes with caps are provided as a molded assembly called an A-ring. The COBAS AMPLICOR automatically performs test specific thermal cycling operations for PCR amplification. Amplified product is automatically transferred to polystyrene specimen cups (D cups) and primer coated magnetic beads are added. Following incubation, unbound material is removed by serial wash steps. Hybridized amplicon is measured by a enzymatically catalyzed color reaction. The intensity of the color is proportional to the amount of infectious organisms present in the specimen and qualitative results are determined based on a specified absorbance cut-off.
The amplification and detection operations can be run in parallel or sequentially depending on the number of samples in the run and user preference. In sequential mode, the analyzer automatically proceeds to sample detection after amplification, and the pipettor transfers amplified products from the A-ring in the thermal cycling segments to the D-cups for hybridization, wash and detection.
2
In parallel operation, a second set of samples is amplified as the first set is detected. After amplification of the first set of specimens is complete, the system pauses for transfer of the first set of amplified A-rings to the ambient temperature chambers. A second set of A-rings are then added to the thermal cycler for amplification, and the automated pipettor transfers amplified product from each of the first set of A-tubes in the ambient temperature segments to D-cups for hybridization, wash and detection.
Statement of Intended Use: V.
The COBAS AMPLICOR is an in vitro diagnostic device intended for use in the amplification and detection steps of the Polymerase Chain Reaction (PCR) process.
Summary of the technological characteristics of the new device in comparison to VI. those of the predicate:
The COBAS AMPLICOR Analyzer is a flexible, automated, bench top analyzer that automates the amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The principles of operation of the COBAS AMPLICOR are substantially equivalent to manual invitro diagnostic PCR testing using general laboratory equipment. The COBAS AMPLICOR Analyzer consists of five major sub-components: (1) a thermal cycler module; (2) an automated pipeting station; (3) an incubation station; (4) a wash station; and (5) a photometer. An internal computer controls and monitors the major components includingsystem and run control, input/output, communication, results calculaton, and system diagnostic tests. The COBAS AMPLICOR Analyzer operating as a system performing automatically various steps such as pipetting, heating and measuring color intensity is substantially equivalent to several currently marketed devices used independently to perform the same functions. The COBAS AMPLICOR is designed to be used in conjunction with AMPLICOR Specimen Preparation Kits (for off-line specimen prepration), AMPLICOR Amplification Kits and COBAS AMPLICOR Detection Kits.
- The AMPLICOR Test for Chlamydia trachomatis used with the Perkin-Elmer 9600 thermal cvcler and Bio-Tek plate reader, and the COBAS AMPLICOR Chlamydia trachomatis are both intended for the qualitative determination of Chlamydia trachomatis from urogenital swab specimens in specimen transport medium and male wine. The COBAS AMPLICOR Chiamydia trachomatis Test is substantially equivalent to the AMPLICOR Chlamydia trachomatis Test (K922906/C, June 15,1993) performed on the Perkin-Elmer 9600 thermal cycler and the Bio-Tek EEL800 (K950104) microtiter plate reader.
Similarities and Differences to Comparable Commercial Products
The specimen preparation, amplification and detection methods used in the COBAS AMPLICOR system are similar to that previously described for the microwell plate AMPLICOR Test. The notable similarities and differences are as follows:
Similarities
- The COBAS AMPLICOR Analyzer provides an automated method for performing the same basic procedures used in manual molecular diagnostic testing. These include, sample handling, reagent preparation, sample incubation, thermal cycling washing and photometric measurement
The procedures used specimen preparation, amplification and detection portions of the COBAS AMPLICOR procedure utilize identical reagent formulations as the AMPLICOR microplate assay. Identical reagent formulations include specimen diluent, master mix, free nucleotides, nucleotide primers and probes, TMB chromagen, peroxide substrate, and wash buffers.
- The COBAS AMPLICOR analyzer performs thermal cycling to tolerances that meet or exceed operational characteristics of conventional general laboratory equipment (e.g. the Perkin Elmer 9600).
3
- The COBAS AMPLICOR analyzer measures absorbance using a fixed wavelength photometer with comparable performance to other conventional general laboratory equipment and to automated clinical instrumentation such as the Roche COBAS MIRA.
Differences
-
The COBAS AMPLICOR system automates all sample handling, washing and pipetting steps for test amplification and detection compared to manual requirements with the AMPLICOR microplate assay.
-
PCR amplified products are captured by hybridization to probe-coated paramagnetic microparticles on the COBAS AMPLICOR compared to probe-coated microwell plates in the AMPLICOR test format.
-
The COBAS AMPLICOR method does not require a stop reagent following the substrate incubation as does the AMPLICOR because the automated system precisely times each portion of the hybridization and detection procedures.
The optical density of the detection system is measured at 660 nm with the COBAS 4. AMPLICOR system compared to 450 nm in the AMPLICOR system. The stop reagent used in the AMPLICOR microplate assay modifies the oxidation state and thus, the absorbance maximum, of the chromophore.
VI. A brief discussion of the nonclinical and clinical performance data
Non-Clinical Performance
Precision
A multi-operator study was performed to determine the reproducibility of the COBAS AMPLICOR Chlamydia trachomatis Test. The study design was based upon the study suggested in the NCCLS document EP5-T2. Three independent operators tested a series of samples once a day for three days. A test run consisted of the amplification and detection of the following samples in triplicate: COBAS AMPLICOR Chlamydia trachomatis Test CT (+) and CT (-) kit controls and specimens that were prepared by spiking AMPLICOR Specimen Transport Medium with infected McCoy cell suspensions to obtain levels of 0, 1, 10 and 50 C. trachomatis IFUIPCR. Calculations were performed using the Analysis of Variance model suggested in the NCCLS document to derive estimates of between-day, between-operator, within-operator, and total variance for the Test at each sample concentration. The results of this study are presented in Table 2.
4
| SAMPLE | ||||||
|---|---|---|---|---|---|---|
| Chlamydia trachomatis Spiked STM (IFU/PCR) | Kit Controls | |||||
| 0 | 1 | 10 | 50 | Negative | Positive | |
| Total Replicates | 27 | 27 | 27 | 27 | 27 | 27 |
| Mean Absorbance | 0.004 | 3.856 | 3.685 | 3.639 | 0.004 | 3.831 |
| Minimum | 0.000 | 3.646 | 3.220 | 3.220 | 0.000 | 3.279 |
| Maximum | 0.017 | 4.000 | 4.000 | 4.000 | 0.011 | 4.000 |
| Between Day Variance | 0.0000 | 0.0000 | 0.0040 | 0.0037 | 0.0000 | 0.0022 |
| Standard Deviation | 0.0013 | 0.0000 | 0.0632 | 0.0610 | 0.0000 | 0.0468 |
| CV (%) | 32.0 | 0.0 | 1.7 | 1.7 | 0.0 | 1.2 |
| Between Operator Variance | 0.0000 | 0.0145 | 0.0271 | 0.0230 | 0.0000 | 0.0587 |
| Standard Deviation | 0.0029 | 0.1206 | 0.1647 | 0.1517 | 0.0027 | 0.2422 |
| CV (%) | 72.4 | 3.1 | 4.5 | 4.2 | 69.7 | 6.3 |
| Within Operator Variance | 0.0000 | 0.0059 | 0.0162 | 0.0125 | 0.0000 | 0.0109 |
| Standard Deviation | 0.0035 | 0.0767 | 0.1274 | 0.1118 | 0.0026 | 0.1045 |
| CV (%) | 87.0 | 2.0 | 3.5 | 3.1 | 67.4 | 2.7 |
| Total Variance | 0.0000 | 0.0204 | 0.0474 | 0.0392 | 0.0000 | 0.0718 |
| Standard Deviation | 0.0047 | 0.1429 | 0.2176 | 0.1980 | 0.0037 | 0.2679 |
| CV (%) | 117.6 | 3.7 | 5.9 | 5.4 | 97.0 | 7.0 |
TABLE 2 COBAS AMPLICOR Chlamydia trachomatis Test Precision Analysis of Variance Test Results
Clinical Performance
The clinical data reported here were obtained using the AMPLICOR Chlamydia trachomatis Test. The AMPLICOR microwell assay and the COBAS AMPLICOR Chlamydia trachomatis Test procedures are highly conserved and differ only in the method of detection. The COBAS AMPLICOR utilizes a magnetic microparticle based solid support compared to microwell plates and the automated analyzer enables the elimination of a endpoint hydrolysis Stop reagent that changes the absorbance maximum of the chromophore. The COBAS AMPLICOR and AMPLICOR Tests use the exact same specimen preparation, detection and amplification reagents, including identical amplification primer (CP24 and CP27) and detection probe (CP35) sequences. Therefore, the equivalent clinical performance is expected from the microwell and automated COBAS Tests.
Clinical Results - COBAS AMPLICOR
To ensure that equivalent clinical performance of the COBAS AMPLICOR Chiamydia trachomatis Test and the AMPLICOR Chlamydia Trachomatis Test are obtained, a comparison of the two test procedures was performed in which 639 clinical specimens were tested. The specimens included 266 endocervical swabs, 93 male urethral swabs, and 280 male urine specimens. Table 3 shows the comparative clinical performance obtained when these specimens were tested by the two test procedures. The results for each specimen type were evaluated for statistical difference in comparative clinical performance using McNemar's Test. For each of the three specimen types tested, the McNemar's Test found a value of P > 0.4. This finding provides strong evidence that there are no differences in the positive and negative results obtained when testing these specimens by either the COBAS AMPLICOR Chlamydia Trachomatis Test or the AMPLICOR Chlamydia Trachomatis Test.
5
Table 3 Comparative Clinical Performance of the COBAS AMPLICOR Chlamydia Trachomatis Test versus the AMPLICOR Chlamydia Trachomatis Test
| Cervical | Male Urethral | Male Urine | ||||
|---|---|---|---|---|---|---|
| Pos | Neg | Pos | Neg | Pos | Neg | |
| COBAS | ||||||
| AMPLICOR | ||||||
| Pos | 34 | 1* | 16 | 1+ | 63 | 4+ |
| Neg | 1" | 230 | 0 | 76 | 5# | 208 |
キキ
AMPLICOR MWP
Two samples were culture positive/MOMP positive; three
samples were culture negative/MOMP positive
VIII. Conclusions
The COBAS AMPLICOR is an automated bench-top analyzer for the in vitro diagnostic analysis of clinical laboratory specimens using PCR based nucleotide amplification methods. The instrument gives substantially equivalent analytical performance to other general laboratory equipment for thermal cycling and photometric detection of colormetric clinical assays. Based on the clinical performance data, substantially equivalent results were obtained for the qualitative COBAS AMPLICOR Chlamydia trachomatis Test on the COBAS AMPLICOR and the Roche AMPLICOR Chlamydia trachomatis Test (microwell plate) performed using the Perkin-Elmer 9600 thermal cycler and a conventional photometric microwell plate reader.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 21 1997
Alex Wesolowski
Director, Regulatory and Clinical Affairs Roche Molecular Systems, Inc. . . . 1080 U.S. Highway 202 Branchburg, New Jersey 08876-1760
K964506 Re : COBAS AMPLICOR™ Analyzer Regulatory Class: I Product Code: JJF Dated: March 24, 1997 Received: March 25, 1997
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 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 The general controls provisions of the Act of the Act. include reguirements 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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.
7
Paqe 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
8
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known)
Device Name: COBAS AMPLICOR™ Analyzer
Indications for Use:
The COBAS AMPLICOR Analyzer is an in vitro diagnostic device intended for use in clinical laboratories for the automation of the AMPLICOR™ Polymerase Chain Reaction test procedures.
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510(k) Number K964506