(36 days)
K 912844/A, K 980056
Not Found
No
The description focuses on automated physical processes (warming, separating, metering, dispensing, incubating, reading signal, calculating results) and standard data output methods (diskette, RS-232). There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an in vitro diagnostic instrument for measuring clinical chemistry analytes, not for direct therapeutic intervention.
Yes.
The "Intended Use / Indications for Use" states that the CARESIDE Analyzer is an "in vitro diagnostic instrument."
No
The device description explicitly states it is a "compact chemistry instrument" that performs physical actions like warming, separating, metering, dispensing, and incubating samples. It also has hardware components like a touch-screen interface, diskette drive, and RS-232 port. This indicates it is a hardware device with integrated software, not a software-only medical device.
Yes, based on the provided text, the CARESIDE Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum. For in vitro diagnostic use." This is the most direct confirmation.
- Device Description: The description details how the device analyzes biological samples (whole blood, plasma, or serum) to measure clinical chemistry analytes, which is a core function of IVD devices.
- Performance Studies: The summary of performance studies mentions "clinical data" and comparing performance to a "legally marketed predicate device," which are typical aspects of demonstrating the safety and effectiveness of an IVD device for regulatory purposes.
- Predicate Device(s): The listing of predicate devices, specifically other analyzers used for clinical chemistry measurements, further reinforces its classification as an IVD.
Therefore, the text clearly and repeatedly identifies the CARESIDE Analyzer as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum. For in vitro diagnostic use. For point of care use.
Product codes (comma separated list FDA assigned to the subject device)
75JJF, CDQ, CEK, CIX, JGS, CEM, CGZ, JJE, CGA, CHH, JFY
Device Description
The CARESIDE Analyzer is a compact chemistry instrument that performs multiple discrete analyses on human whole blood, plasma, or serum samples. The CARESDIDE Analyzer is semi-automated: the only operator steps are the addition of the sample to the test cartridge and the insertion of the dosed cartridge into the instrument. The CARESIDE Analyzer automatically warms, separates, meters, dispenses, and incubates the sample before reading the signal and calculating results. The CARESIDE Analyzer is intended only for use with CARESIDE test cartridges.
The instrument is controlled through a touch-screen interface. Results are displayed on the interface screen. Results can also be downloaded on to a 3-1/2 inch diskette or to a computer via a RS-232 port.
The CARESIDE Analyzer accepts up to 6 test cartridges from a single patient at the same time.
The user enters the patient identification and test(s) to be performed via the touch screen by following a series of menus and prompts. Next, the user obtains the required test cartridge(s) from refrigerated storage and removes the cartridge from its individual hermetically sealed package. Each CARESIDE test cartridge contains both human readable and barcode labeling. Test specific requirements, such as specimen type, sample storage, and reagent storage are provided in testspecific package inserts. See CARESIDE package inserts and CARESIDE Analyzer Operator's Manual (Appendix 2 and 3).
The user doses the cartridge by lifting the cartridge lid, filling the cartridge Sample Well with sample via a dropper or pipette, and closing the cartridge lid. The user inserts the cartridge into the instrument when prompted. During the subsequent operations, the cartridge is held securely on a circular platter, which is automatically weight balanced. The cartridge is rotated beneath a bar code reader which reads the cartridge name, lot identification, calibration data, and expiration date from the barcode located on the top surface of the disposable cartridge. The cartridge chamber is heated and the cartridges are equilibrated at 37 ℃. The cartridges are spun to initially transfer the sample from the Sample Well to the Separation Well, metering passages, and overflow well and then to separate the blood cells (if present) from the plasma. After spinning, 8.5 µl of sample is automatically dispensed onto the analytical element of the cartridge by two plungers, one of which seals the cartridge vent hole and other which depresses the membrane that covers the Sample Well. After dispensing, the instrument takes any differential potentiometry readings via pins that move into contact with the electrodes on the slide of any CARESIDE ELECTROLYTE (NA+K+CL) cartridge present. Next, the instrument begins taking reflectance readings while spinning. Light emitting diodes (LEDs) are arranged radially beneath the film reading position. The reflected light is detected by photodiodes that convert the light energy to electrical signals. Reflectance is measured from the center of the bottom surface of the reagent film through the optically clear plastic transparent support and also from white and black standards that are present on the cartridge platter for continuous reference measurements. After all readings are taken, the spinning cartridges are stopped and the cartridges are ejected into a removable waste bin.
The reflectance readings are taken at a fixed angle from the incident light at a regular interval. Multiple readings at each time point are taken across the film, From each series of readings a single digital signal is stored for final data reduction. From the signals corresponding to the desired time point(s), the reflectance is calculated based on the signals obtained from the film and the white and black standards. Test specific algorithms are used to calculate results from the reflectance.
The CARESIDE Analyzer utilizes CARESIDE film chemistry and electrochemistry cartridges. The CARESIDE cartridges for individual chemistry tests were the subject of separate past 510(k) submissions as well as future 510(k) submissions. These cartridges consist of a pre-analytical element and an analytical element.
For electrochemistry cartridge, the pre-analytical element consists of a plastic cartridge consisting of 4 parts which holds an electrochemical slide in a plastic housing.
For the film chemistry cartridge, the pre-analytical element consists of a plastic cartridge consisting of 5 parts which holds a rectangular piece of dry reagent film. A top and bottom housing form a series of channel and wells in the cartridge base. On top of the cartridge base is a hinged lid with a vent hole and a plastic membrane to cover the Sample Well when the lid is closed. Whole blood, plasma or is introduced into the Sample Well of the cartridge. During centrifugation within the instrument, the force of centrifugation moves the sample to the Separation Well, to the various channels and chambers of the test cartridge and separates the blood cells from the plasma. Next, the flow of the plasma or serum (if applicable) from the metering channel is initiated when the Sample Well is pressurized by deformation of its plastic membrane by a plunger within the instrument while the vent hole is sealed by another plunger. The pressure forces the plasma or serum out of the sample delivery passage onto the analytical element.
The analytical elements consist of a test-specific multi-layer film or ionselective electrode slide. Films consist of a combination of layers. A typical film consists of 3 to 6 layers and ranges from about 0.5 to 0.7 mm in thickness. Films are approximately 1 x 1 cm.
The CARESIDE test cartridges are individually bar coded and packaged. The test cartridge package is hermetically sealed to assure stability over the shelf-life of the cartridge. The following are film layers used for various test cartridges.
. Spreading layer - distributes the sample evenly on the film
Substrate layer - provides substrates for enzymatic reactions
Reaction layer provides an environment and time for a reaction to proceed .
Reflection layer -- provides a background upon which the formed dye or . colored substance is irradiated with light of a specific wavelength.
. Detection layer - provides a layer in which the biochemical reaction is coupled to a detectable chromogen
. Suction layer - provides a layer to draw fluid
Absorbing layer provides a layer in which a molecule of interest is ● absorbed
Porous layer provides a layer to allow gas to permeate while retaining . other substances
Buffer layer provides a medium with a defined stable pH for a reaction to . proceed
Interference elimination layer provides a reaction to eliminate a potential . interferent
Transparent support a transparent material, typically mylar, used to ● support the other layers and allow the incident and reflected light to pass.
Similar to other automated instruments in commercial distribution, the CARESIDE Analyzer and reagent cartridges are factory-calibrated. The user does not perform calibration.
The user receives CARESIDE cartridges that are labeled with a barcode. This barcode contains lot-specific coefficients for a polynomial equation and is scanned by the CARESIDE Analyzer. The observed reflectance (ODr) is adjusted by inputting it into the equation. The patient result is calculated from the adjusted ODr using the polynomial describing the master dose - response curve.
The instrument is calibrated during each test by automatically reading a black and white reflectance standard and making adjustments if necessary.
The user performs periodic quality control and calibration verification to confirm maintenance of calibration over time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The clinical data provided demonstrate that the CARESIDE Analyzer, like other The onlined data provided comes. Is safe and effective for point of care as well as laboratory use, and performs equivalently or better than the other legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 912844/A, K 980056
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.
Not Found
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).
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
CARESIDE, Inc. Page 9
DEC - 2 1999
510(K) SUMMARY: CARESIDE™ SAFETY AN IV. EFFECTIVENESS
Applicant Information I.
- A. Applicant Name
- Applicant/Manufacturer Address B.
- C. Telephone Number
- Contact Person D.
- FAX Number E.
- F. e-Mail Address
- G. Date 510(k) Summary prepared
II. Device Information
- A. Device Name (Trade)
- Device Name (Classification) B.
- C. Device Classification
CARESIDE, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 AsarchK@CARESIDE.com October 25, 1999
CARESIDE Analyzer Microchemistry instrument for clinical use Clinical Chemistry Panel Microchemistry instrument for clinical use Regulation Number: 21 CFR 862.2170 Regulatory Class 2 75JJF, CDQ, CEK, Classification Number: CIX, JGS, CEM, CGZ, JJE Not applicable
D. Special controls and performance standards
III. Substantial Equivalence Claim
General equivalency claim A.
The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, and serum. The instrument utilizes reflectance photometry and differential potentiometry measurement for analyte quantitation. Together, the device and the test cartridge perform most of the pre-analytical, analytical, and post-analytical test steps. The CARESIDE Analyzer reads calibration information from the bar code on the cartridge label, warms the cartridge and sample, separates the blood cells if the sample is not preprocessed, meters the sample, dispenses the metered volume, and reads the signal.
For film chemistry cartridges, the diffuse reflectance is read off of the reagent film using light emitting diode/photodiode sets spaced radially under the reagent film. Reflectance is The analyte concentration is read at defined times during the reaction period. proportional to the concentration of dye on the film.
For electrochemistry cartridges voltage differences are measured. The analyte concentration is proportional to the voltage difference between the sample electrode and the reference solution electrode.
The ability to monitor analyte-specific biochemical reactions in dry film by reflectance and via ion-selective electrodes are widely recognized and have gained widespread acceptance for use in chemistry assays. Microchemistry instruments are already on the These products utilize reflectance photometry from dry film and ion-U.S. market. selective electrodes. For example,
- . Vitros DT 60/DTSC/DTE II Module (formerly Kodak Ektachem DT 60/DTSC/DTE II), Johnson & Johnson Clinical Diagnostics (Operator's Manual available upon request)
1
- B. Specific equivalency claim
The CARESIDE Analyzer is substantially equivalent in principle, intended use, and clinical performance to itself and to the currently marketed Vitros DT 60/DTSC/DTE II Module.
| 1. | Name of Predicate Device 1: | Johnson and Johnson's DT
60/DTSC/DTE II(formerly Kodak
Ektachem DT 60/DTSC/DTE II
System) |
|----|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Predicate Device 510K number:
Product Code: | K 912844/A
75JJE, JJF, others |
| 2. | Name of Predicate Device 2:
Predicate Device 510K number:
Product Code: | CARESIDE Analyzer (for lab use)
K 980056
JJF, CDQ, CEK, CIX |
IV. Device Description
- A. Explanation of Device Function
-
- Instrument
-
The CARESIDE Analyzer is a compact chemistry instrument that performs multiple discrete analyses on human whole blood, plasma, or serum samples. The CARESDIDE Analyzer is semi-automated: the only operator steps are the addition of the sample to the test cartridge and the insertion of the dosed cartridge into the instrument. The CARESIDE Analyzer automatically warms, separates, meters, dispenses, and incubates the sample before reading the signal and calculating results. The CARESIDE Analyzer is intended only for use with CARESIDE test cartridges.
The instrument is controlled through a touch-screen interface. Results are displayed on the interface screen. Results can also be downloaded on to a 3-1/2 inch diskette or to a computer via a RS-232 port.
The CARESIDE Analyzer accepts up to 6 test cartridges from a single patient at the same time.
The user enters the patient identification and test(s) to be performed via the touch screen by following a series of menus and prompts. Next, the user obtains the required test cartridge(s) from refrigerated storage and removes the cartridge from its individual hermetically sealed package. Each CARESIDE test cartridge contains both human readable and barcode labeling. Test specific requirements, such as specimen type, sample storage, and reagent storage are provided in testspecific package inserts. See CARESIDE package inserts and CARESIDE Analyzer Operator's Manual (Appendix 2 and 3).
The user doses the cartridge by lifting the cartridge lid, filling the cartridge Sample Well with sample via a dropper or pipette, and closing the cartridge lid. The user inserts the cartridge into the instrument when prompted. During the subsequent operations, the cartridge is held securely on a circular platter, which is automatically weight balanced. The cartridge is rotated beneath a bar code reader which reads the cartridge name, lot identification, calibration data, and expiration date from the barcode located on the top surface of the disposable cartridge. The cartridge chamber is heated and the cartridges are equilibrated at 37 ℃. The cartridges are spun to initially transfer the sample from the Sample Well to the Separation Well, metering passages, and overflow well and then to separate the blood cells (if present) from the sample. After spinning, 8.5 µl of sample is automatically dispensed onto the analytical element of the cartridge by two plungers, one of which seals the cartridge vent hole and other which depresses the membrane that covers the Sample Well. After dispensing, the instrument takes any differential potentiometry readings via pins that move into
2
contact with the electrodes on the slide of any CARESIDE ELECTROLYTE (NA+K+CL) cartridge present. Next, the instrument begins taking reflectance readings while spinning. Light emitting diodes (LEDs) are arranged radially beneath the film reading position. The reflected light is detected by photodiodes that convert the light energy to electrical signals. Reflectance is measured from the center of the bottom surface of the reagent film through the optically clear plastic transparent support and also from white and black standards that are present on the cartridge platter for continuous reference measurements. After all readings are taken, the spinning cartridges are stopped and the cartridges are ejected into a removable waste bin.
The reflectance readings are taken at a fixed angle from the incident light at a regular interval. Multiple readings at each time point are taken across the film, From each series of readings a single digital signal is stored for final data reduction. From the signals corresponding to the desired time point(s), the reflectance is calculated based on the signals obtained from the film and the white and black standards. Test specific algorithms are used to calculate results from the reflectance.
-
- Test Cartridges
The CARESIDE Analyzer utilizes CARESIDE film chemistry and electrochemistry cartridges. The CARESIDE cartridges for individual chemistry tests were the subject of separate past 510(k) submissions as well as future 510(k) submissions. These cartridges consist of a pre-analytical element and an analytical element.
- Test Cartridges
For electrochemistry cartridge, the pre-analytical element consists of a plastic cartridge consisting of 4 parts which holds an electrochemical slide in a plastic housing.
For the film chemistry cartridge, the pre-analytical element consists of a plastic cartridge consisting of 5 parts which holds a rectangular piece of dry reagent film. A top and bottom housing form a series of channel and wells in the cartridge base. On top of the cartridge base is a hinged lid with a vent hole and a plastic membrane to cover the Sample Well when the lid is closed. Whole blood, plasma or is introduced into the Sample Well of the cartridge. During centrifugation within the instrument, the force of centrifugation moves the sample to the Separation Well, to the various channels and chambers of the test cartridge and separates the blood cells from the plasma. Next, the flow of the plasma or serum (if applicable) from the metering channel is initiated when the Sample Well is pressurized by deformation of its plastic membrane by a plunger within the instrument while the vent hole is sealed by another plunger. The pressure forces the plasma or serum out of the sample delivery passage onto the analytical element.
The analytical elements consist of a test-specific multi-layer film or ionselective electrode slide. Films consist of a combination of layers. A typical film consists of 3 to 6 layers and ranges from about 0.5 to 0.7 mm in thickness. Films are approximately 1 x 1 cm.
The CARESIDE test cartridges are individually bar coded and packaged. The test cartridge package is hermetically sealed to assure stability over the shelf-life of the cartridge. The following are film layers used for various test cartridges.
- . Spreading layer - distributes the sample evenly on the film
- Substrate layer - provides substrates for enzymatic reactions
- Reaction layer provides an environment and time for a reaction to proceed .
- Reflection layer -- provides a background upon which the formed dye or . colored substance is irradiated with light of a specific wavelength.
- . Detection layer - provides a layer in which the biochemical reaction is coupled to a detectable chromogen
- . Suction layer - provides a layer to draw fluid
3
- Absorbing layer provides a layer in which a molecule of interest is ● absorbed
- Porous layer provides a layer to allow gas to permeate while retaining . other substances
- Buffer layer provides a medium with a defined stable pH for a reaction to . proceed
- Interference elimination layer provides a reaction to eliminate a potential . interferent
- Transparent support a transparent material, typically mylar, used to ● support the other layers and allow the incident and reflected light to pass.
3. Calibration
Similar to other automated instruments in commercial distribution, the CARESIDE Analyzer and reagent cartridges are factory-calibrated. The user does not perform calibration.
The user receives CARESIDE cartridges that are labeled with a barcode. This barcode contains lot-specific coefficients for a polynomial equation and is scanned by the CARESIDE Analyzer. The observed reflectance (ODr) is adjusted by inputting it into the equation. The patient result is calculated from the adjusted ODr using the polynomial describing the master dose - response curve.
The instrument is calibrated during each test by automatically reading a black and white reflectance standard and making adjustments if necessary.
The user performs periodic quality control and calibration verification to confirm maintenance of calibration over time.
B. Test Summary
Measurement of each analyte from blood using the CARESIDE Analyzer is useful in the diagnosis and treatment of patients with a variety of diseases as described in each test cartridge package insert.
V. Intended Use
A. Intended Use
The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum.
B. Indications for Use
For in vitro diagnostic use. For point of care use.
4
VI. Technological Characteristics
Similarities A.
| | CARESIDE Analyzer | Vitros DT 60/DTSC/DTE II
System |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for the measurement of
various analytes | Same |
| Indications | For in vitro diagnostic use For
point of care use | Same |
| Type | Quantitative | Same |
| Principle of method | Chemistry - Dry film based.
Chromogen quantitated by
reflectance measurement at single
and multiple reaction times for
end-point and rate measurements.
Electrochemistry - ion-selective
electrodes and differential
potentiometry | Same |
| Compatible reagents | CARESIDE cartridges | Vitros DT Slides |
| Menu | Currently 32 direct and calculated
tests | Approx 37 direct and calculated
tests |
| Specimen dilution | Not required | Not required |
| Detector | Reflectance and differential
potentiometry | Reflectance and differential
potentiometry |
| Test time | Approx 4 minutes warm-up (on-
board) plus up to 6 minutes test
time. | 15 minutes warm-up (off-line)
plus 5 minutes test time. |
| Throughput (approximate) | 24 test/hours (no centrifugation
required) | 10 minute centrifugation (typical)
required for sample preparation
(quoted throughput is without
centrifugation) |
| | | DT60 II 65 |
| | | DTSC II 15 |
| | | DTE 15 |
| Sample Type | Whole blood, plasma and serum
(for whole blood applied sample
plasma is test sample except for
hemoglobin and Na, K, Cl)
Tests for urine not available. | serum, plasma
whole blood not acceptable
except for hemoglobin
Urine for some tests |
| Specimen volume | 90 ± 10 µl applied volume, 8.5 µl
test volume | 10 µl |
| Calibration | Calibration information bar coded
on each cartridge. Calibration
information may change with
each lot. | Run Kodak Ektachem DT II
calibrators whenever a new slide
lot is used or when necessary |
| Quality Control | External Wet
Internal and External Dry. | External Wet |
| Incubation Temperature | 37 °C | 37 °C |
| | CARESIDE Analyzer | DT 60/DTSC/DTE II |
| Access | Single patient per platter run | Single or multiple patient |
| Queuing | 6 cartridges | Multiple slides |
| Module | Single | Multiple |
| Software updating | 3-1/2 inch floppy | EPROM (CDM, CLM) |
| Direct blood specimen | Yes, whole blood | No, requires separation of whole
blood prior to sample application |
| Accurate pipetting | Not required | Required |
| Reagent pre-warming | Not required | Required |
5
Differences B.
Comparative Performance Characteristics C. Comparative Performance Characteristics (see individual test 510k submissions)
D. Conclusion
The clinical data provided demonstrate that the CARESIDE Analyzer, like other The onlined data provided comes. Is safe and effective for point of care as well as laboratory use, and performs equivalently or better than the other legally marketed predicate device.
6
Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized symbol resembling a person with flowing hair or fabric, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 2 1999
Kenneth B. Asarch, Ph.D. VP Quality Systems and Regulatory Affairs Careside, Inc. 6100 Bristol Parkway Culver City, California 90230
Re: K993634
Trade Name: CARESIDE™ Analyzer System for Point of Care Use Regulatory Class: I Product Code: JJF Regulatory Class: II Product Codes: CGA, CHH, JGS, CEM, CGZ, CDQ, JFY Dated: October 25, 1999 Received: October 27, 1999
Dear Dr. Asarch:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic 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
7
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INDICATIONS FOR USE
510(k) Number:
Device Name:
CARESIDE™ Sytem
Indications for use:
The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in whole blood, plasma, and serum. It is intended for in vitro diagnostic use and is intended for point of care use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993634
Cooper
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)