(36 days)
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.
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 provided text describes the CARESIDE™ Analyzer, an in vitro diagnostic instrument for measuring clinical chemistry analytes. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance (510(k)), rather than presenting a detailed study proving performance against explicit acceptance criteria.
However, based on the information provided, we can infer the approach taken for performance evaluation and how "acceptance criteria" are implied through comparison with a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in the format requested (e.g., "Accuracy must be within X% of reference method"). Instead, it relies on demonstrating substantial equivalence to an existing legally marketed predicate device (the Vitros DT 60/DTSC/DTE II Module and their own previously cleared CARESIDE Analyzer for lab use).
For each analyte the CARESIDE Analyzer measures, its performance would have been compared to the predicate device. The general "acceptance criteria" for regulatory clearance in this context are that the new device's performance is equivalent or better than the predicate device for its intended use, without raising new questions of safety or effectiveness.
While specific percentage differences or statistical thresholds are not given in this summary, the "Comparative Performance Characteristics" section states: "The clinical data provided demonstrate that the CARESIDE Analyzer... performs equivalently or better than the other legally marketed predicate device." This implies that for each analyte, the observed agreement, correlation, bias, and precision met the FDA's criteria for substantial equivalence when compared to existing devices.
To illustrate how such a table would be structured if explicit criteria were available, and how the performance statement translates, let's use a hypothetical example for a single analyte (e.g., Glucose) and infer the comparison:
| Acceptance Criteria Category | Specific Acceptance Criterion (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (Implied from Summary) |
|---|---|---|
| Accuracy (Correlation) | Correlation coefficient (R) vs. Predicate Device ≥ 0.95 (Hypothetical) | "Equivalent or better" than Predicate Device |
| Accuracy (Bias) | Mean bias vs. Predicate Device ≤ X% (Hypothetical) | "Equivalent or better" than Predicate Device |
| Precision (CV%) | %CV ≤ Y% for specified concentration ranges (Hypothetical) | "Equivalent or better" than Predicate Device |
| Measurement Range | Analytical Measuring Range (AMR) similar to Predicate Device | Similar to Predicate Device |
| Interferences | No significant interference at physiological levels (Hypothetical) | Comparable to Predicate Device |
The document points out that details for each individual test's 510(k) submission would contain the specific performance data ("see individual test 510k submissions").
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "clinical data provided" without further detail. This information would typically be found in the specific validation studies submitted with each individual test cartridge's 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a clinical chemistry analyzer, the "ground truth" for the test set would typically be established by comparison to a recognized reference method or a predicate device, as opposed to expert consensus on images or clinical assessments. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth is not directly applicable in the same way it would be for, say, an AI-powered diagnostic imaging device.
For a clinical chemistry analyzer, consistency and agreement with a predicate device or a gold standard laboratory method are the primary measures of ground truth. The "experts" involved would be clinical chemists, laboratory scientists, or medical technologists who perform the reference measurements and analyze the results. Their qualifications would include relevant certifications and experience in clinical laboratory testing.
4. Adjudication Method for the Test Set
As the ground truth is established by quantitative comparison to reference methods or a predicate device, an "adjudication method" in the sense of a committee resolving disagreements (e.g., 2+1, 3+1) is not typically used for clinical chemistry results. The differences between the new device and the reference/predicate would be analyzed statistically to determine agreement, bias, and correlation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used to evaluate the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, particularly in fields like radiology or pathology where human interpretation is central. The CARESIDE Analyzer is a standalone instrument that provides quantitative measurements, not an aid designed to improve human reader performance in interpreting complex data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the information provided describes the performance of the CARESIDE Analyzer as a standalone device. The instrument performs the measurement and calculation of results directly from the sample without human interpretation of raw signals. The comparison in the submission (as inferred) is between the measurements obtained by the CARESIDE Analyzer and those obtained by predicate devices or reference methods.
7. The Type of Ground Truth Used
The ground truth used for validating the CARESIDE Analyzer's performance would primarily be:
- Reference Methods: Measurements obtained from established, accurate laboratory methods (e.g., spectrophotometry, chromatography, highly accurate ion-selective electrodes) in a qualified clinical laboratory.
- Predicate Device Data: Performance data obtained from the legally marketed predicate device (Vitros DT 60/DTSC/DTE II Module and the CARESIDE Analyzer for lab use) on the same samples.
The document states that the individual test (analyte) cartridges were subject to separate 510(k) submissions, and those submissions would contain the detailed ground truth information for each specific analyte.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. The CARESIDE Analyzer is factory-calibrated, and lot-specific calibration coefficients are provided via barcodes on the cartridges. This implies that extensive calibration and characterization data (which could be considered a form of "training data" for the internal algorithms/calibration curves) were collected by the manufacturer during development and manufacturing. However, the exact sample sizes for this internal development and calibration are not disclosed in this regulatory summary.
9. How the Ground Truth for the Training Set was Established
The ground truth for establishing the factory calibration (which is analogous to the "training set" for the device's inherent algorithms) would typically involve:
- Certified Reference Materials (CRMs) or Standard Solutions: Samples with known, highly accurate concentrations of analytes.
- Split Sample Analysis: Running samples on both the CARESIDE system and established reference methods (or predicate devices) in a robust laboratory setting to generate the dose-response curves and calibration coefficients.
- Statistical Modeling: Using the data from CRMs and split samples to derive the polynomial equations that convert raw reflectance/potentiometry signals into analyte concentrations.
The document mentions that "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." This "master dose-response curve" and its associated polynomial are derived from this extensive calibration process using samples with established ground truth. This process ensures the instrument correctly interprets its raw signals into clinically meaningful concentrations across its analytical measuring range.
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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)
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- 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 DT60/DTSC/DTE II(formerly KodakEktachem DT 60/DTSC/DTE IISystem) |
|---|---|---|
| Predicate Device 510K number:Product Code: | K 912844/A75JJE, JJF, others | |
| 2. | Name of Predicate Device 2:Predicate Device 510K number:Product Code: | CARESIDE Analyzer (for lab use)K 980056JJF, 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
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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
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- 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.
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VI. Technological Characteristics
Similarities A.
| CARESIDE Analyzer | Vitros DT 60/DTSC/DTE IISystem | |
|---|---|---|
| Intended Use | Intended for the measurement ofvarious analytes | Same |
| Indications | For in vitro diagnostic use Forpoint of care use | Same |
| Type | Quantitative | Same |
| Principle of method | Chemistry - Dry film based.Chromogen quantitated byreflectance measurement at singleand multiple reaction times forend-point and rate measurements.Electrochemistry - ion-selectiveelectrodes and differentialpotentiometry | Same |
| Compatible reagents | CARESIDE cartridges | Vitros DT Slides |
| Menu | Currently 32 direct and calculatedtests | Approx 37 direct and calculatedtests |
| Specimen dilution | Not required | Not required |
| Detector | Reflectance and differentialpotentiometry | Reflectance and differentialpotentiometry |
| Test time | Approx 4 minutes warm-up (on-board) plus up to 6 minutes testtime. | 15 minutes warm-up (off-line)plus 5 minutes test time. |
| Throughput (approximate) | 24 test/hours (no centrifugationrequired) | 10 minute centrifugation (typical)required for sample preparation(quoted throughput is withoutcentrifugation) |
| DT60 II 65 | ||
| DTSC II 15 | ||
| DTE 15 | ||
| Sample Type | Whole blood, plasma and serum(for whole blood applied sampleplasma is test sample except forhemoglobin and Na, K, Cl)Tests for urine not available. | serum, plasmawhole blood not acceptableexcept for hemoglobinUrine for some tests |
| Specimen volume | 90 ± 10 µl applied volume, 8.5 µltest volume | 10 µl |
| Calibration | Calibration information bar codedon each cartridge. Calibrationinformation may change witheach lot. | Run Kodak Ektachem DT IIcalibrators whenever a new slidelot is used or when necessary |
| Quality Control | External WetInternal 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 wholeblood prior to sample application |
| Accurate pipetting | Not required | Required |
| Reagent pre-warming | Not required | Required |
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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.
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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
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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
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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)
§ 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.