(59 days)
This product is intended for use with Exigent Diagnostics Cartridges when used by laboratory professionals for the in vitro measurement of various clinical chemistry analytes in human blood.
This product is indicated for in vitro measurement of various clinical chemistry analytes in human blood.
The Exigent Diagnostics CareSide™ System utilizes individual (analyte specific) test cartridges to perform a variety of clinical blood tests. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. The Exigent Diagnostics CareSide™ Analyzer automatically performs up to 6 quantitative test results in approximately ten minutes using approximately 85 microliters of human blood per test. Results are provided on-screen, and may be transferred to a floppy disk for subsequent uploading to a laboratory information system. The Exigent Diagnostics CareSide™ System components include: CareSide™ Analyzer and Analyte-specific Cartridge(s).
The CareSide™ Analyzer is a compact tabletop chemistry analyzer that performs multiple discrete analyses on human whole blood, plasma, or serum specimens. The CareSide™ analyzer is semi-automated: the only operator intervention is the addition of the specimen to the test cartridge and the insertion of the dosed cartridge into the analyzer. The CareSide™ Analyzer automatically warms, separates, meters, dispenses, and incubates the specimen before reading the signal and calculating results. The CareSide™ Analyzer is intended only for use with Exigent Diagnostics CareSide™ test cartridges.
The provided text describes a 510(k) summary for the Exigent Diagnostics CareSide™ Analyzer, submitted on February 23, 1998. It details the device's characteristics and compares its performance to a predicate device, the Vitros DT 60 II System, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, Vitros DT 60 II System, aiming for "as safe, effective, and performs as well as or better than" the predicate. The performance characteristics evaluated are Precision, Relative Accuracy, Linearity, Interference, and Detection Limit.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported CareSide™ Performance |
|---|---|---|
| Precision | Typical total CV 1.5% to 5.2% (for 4 tests evaluated by predicate) | Typical total CV 3.1% to 8.5% (for 4 tests evaluated) |
| Relative Accuracy | Not explicitly stated for predicate; implied to be acceptable for predicate | Mean difference [Vitros - CareSide™] from method comparison means is test specific (3% for 4 tests evaluated) |
| Linearity | Not provided for predicate; implied to be acceptable for predicate | Correlation coefficient >= 0.95 |
| Interference | Not provided for predicate; implied to be acceptable for predicate | Susceptibility to interference is test specific. |
| Detection Limit | Not provided for predicate; implied to be acceptable for predicate | Test specific. |
Note: The phrasing "as safe, effective, and performs as well as or better than the legally marketed predicate device" suggests that matching or improving upon the predicate's performance is the acceptance criterion. However, for "Precision," the CareSide™'s reported CV range (3.1% to 8.5%) is wider than the predicate's (1.5% to 5.2%), which might indicate worse precision. The submission, nonetheless, concludes that the data "demonstrate that the CareSide™ Analyzer is as safe, effective, and performs as well as or better than" the predicate, implying the FDA accepted these differences as not impacting substantial equivalence for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the comparative performance studies (Precision, Relative Accuracy, Linearity, Interference, Detection Limit). It mentions "4 tests evaluated" for Precision and Relative Accuracy, but this refers to the number of different types of chemical analytes for which performance was assessed, not the number of samples used for each evaluative test.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. Given that this is a clinical chemistry analyzer, the "ground truth" would typically come from a reference method run by a certified clinical laboratory, rather than expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of device (a micro chemistry analyzer) does not typically involve expert adjudication in the way, for example, a diagnostic imaging device might. Its performance is measured against reference methods, not subjective expert opinion.
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 performed. MRMC studies are typically relevant for diagnostic devices where human interpretation is a key component, such as radiology or pathology imaging, to assess how AI assistance impacts human reader performance. This device is an automated analyzer, so such a study would not be applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the data presented ("Comparative Performance Characteristics") are for the standalone performance of the CareSide™ Analyzer. The device is described as "semi-automated" requiring only operator intervention for specimen addition and cartridge insertion, with the analyzer then automatically performing all steps and calculating results. The performance metrics (Precision, Accuracy, Linearity) reflect the algorithm's direct output compared to standard methods.
7. The Type of Ground Truth Used
The ground truth for assessing the CareSide™ Analyzer's performance implicitly comes from comparison to a legally marketed predicate device (Vitros DT 60 II System) and established laboratory reference methods.
- For Relative Accuracy, the comparison is directly stated: "Mean difference [Vitros - CareSide™]". This implies the Vitros results are considered a form of "ground truth" or a highly correlated reference.
- For Precision, this is measured inherently by repeated tests on the same sample, with the expectation that results should be tightly clustered.
- For Linearity and Detection Limit, these would be established by testing samples with known, varied concentrations or concentrations near the expected limit, using reference methods to determine the true values.
Therefore, the ground truth is based on established reference laboratory methods and comparison to a predicate device's performance.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This submission is for a device based on established chemical principles and reflectance photometry, not a machine learning or AI algorithm that would typically require a distinct training set in the modern sense. The "master dose-response curve" used for calculation is likely derived from validation studies during the device's development, but specific details on the dataset used for this are not given.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a separate "training set" in the context of modern AI/ML development isn't explicitly described for this device. The "master dose-response curve" and "lot-specific coefficients" are central to the analyzer's calculations. These would have been established during the development and manufacturing process using samples with known analyte concentrations, validated through standard laboratory reference methods, to ensure accurate quantification of reflectance to concentration. However, the exact methodology and ground truth establishment for these internal calibration curves are not detailed in this 510(k) summary.
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V. 510(k) Summary:
CareSide™ Analyzer Safety and Effectiveness
MAR - 6 1998
Applicant Information I.
- Applicant Name A.
- Applicant/Manufacturer Address B.
- Telephone Number C.
- D. Contact Person
- E. FAX Number
- e-Mail Address F.
- Date 510(k) Summary prepared G.
Device Information II.
- A. Device Name (Trade)
- B. Device Name (Classification)
- C. Device Classification
CareSide™ Analyzer
Exigent Diagnostics, Inc.
Kenneth B. Asarch, Pharm.D., Ph.D.
6100 Bristol Parkway
310-338-6767
310-338-6789
February 23, 1998
Culver City, CA 90230
Micro chemistry analyzer for clinical use Clinical chemistry panel Micro chemistry analyzer for clinical use Regulation Number: 21 CFR 862.2170 Regulatory Class I Classification Number: 75JJF Tier I None applicable
- D. Device Tier
- Special controls and E. performance standards
III. Substantial Equivalence Claim
- A. General equivalency claim
The ability to monitor analyte-specific biochemical reactions in dry film and other formats by reflectance and other techniques is widely recognized and has gained widespread acceptance for use in chemistry assays. Micro chemistry analyzers are already on the U.S. market. These products utilize dry film and other formats, and use reflectance and other types of signals. For example,
Johnson & Johnson Clinical Diagnostics, formerly Kodak Vitros DT 60 II Ektachem DT 60 II (analyzer using reflectance photometry and electrochemical measurement for signal detection)
Miles/Ames (analyzer using Seralyzer Reflectance Photometer formerly reflectance photometry for signal detection)
- B. Specific equivalency claim
The CareSide™ Analyzer is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros DT 60 II/DTSC II Module.
| Name of Predicate Device: | Johnson and Johnson's Vitros DT 60 II/DTSC II/I(formerly Kodak Ektachem DT 60 II System) |
|---|---|
| Predicate Device 510K number: | K 912844/A |
| Product Code: | 75JJE |
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IV. Device Description
CareSide™ System Overview A.
The Exigent Diagnostics CareSide™ System utilizes individual (analyte specific) test cartridges to perform a variety of clinical blood tests. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. The Exigent Diagnostics CareSide™ Analyzer automatically performs up to 6 quantitative test results in approximately ten minutes using approximately 85 microliters of human blood per test. Results are provided on-screen, and may be transferred to a floppy disk for subsequent uploading to a laboratory information system. The Exigent Diagnostics CareSide™ System components include:
- CareSide™ Analyzer t
- . Analyte-specific Cartridge(s)
CareSide Cartridge™ Description B.
The CareSide™ Test Cartridge, a single use analyte-specific cartridge, performs the following functions: reagent and specimen temperature equilibration, sample separation, sample metering, sample dispensing, test incubation, and colorimetric detection. Each cartridge (patents pending) contains all reagents necessary to perform an analyte measurement.
The CareSide™ test cartridges are individually bar coded and packaged, containing both human readable and barcode labeling. The test cartridge package is hermetically sealed to assure stability over the shelf-life of the cartridge. Test specific requirements are provided in test specific package inserts. These cartridges consist of a pre-analytical element and an analytical element.
- Pre-analytical Element The pre-analytical element consists of a plastic 1. cartridge consisting of a series of channel and wells. On top of the cartridge is a hinged lid and a plastic membrane covered opening. The assembled cartridge contains various channels and chambers which, upon centrifugation within the Analyzer, separates the blood cells from the plasma or serum. The plasma or serum flow from the metering channel is initiated when the specimen deposition well is pressurized by deformation of its plastic cover within the analyzer. The pressure forces the plasma or serum out of the sample delivery passage onto the analytical element.
-
- The analytical elements consist of a multi-layer film. Analytical Element Each different chemistry cartridge differs only with respect to the multi-layer film which is described in the analyte-specific test cartridge package insert.
C. CareSide™ Analyzer Description and explanation of Device Function
The CareSide™ Analyzer is a compact tabletop chemistry analyzer that performs multiple discrete analyses on human whole blood, plasma, or serum specimens. The CareSide™ analyzer is semi-automated: the only operator intervention is the addition of the specimen to the test cartridge and the insertion of the dosed cartridge into the analyzer. The CareSide™ Analyzer automatically warms, separates, meters, dispenses, The and incubates the specimen before reading the signal and calculating results. CareSide™ Analyzer is intended only for use with Exigent Diagnostics CareSide™ test cartridges.
The user enters the patient identification and test(s) to be performed via the touch screen by following a series of menus and prompts. The CareSide™ Analyzer accepts up to 6 test cartridges from a single patient at the same time. Next, the user obtains the required test cartridge(s) from refrigerated storage and removes the cartridge from its individual hermetically sealed package.
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Once loaded, the analyzer spins the cartridge(s) to heat the cartridge(s) and the contained specimen(s) to the reaction temperature and to to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge spins, the cells accumulate in the separation well. A defined volume of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well. To dispense the metered volume of sample onto the film, a plunger displaces a flexible seal that covers the sample deposition well. As the flexible seal is displaced, air is forced through the metering passage, forcing the sample out and onto the reagent film. As the cartridges spin, the film passes by one of 6 LED/photodiode pairs. The LED/photodiodes perform reflectance measurements at a specified time(s). The analyzer uses the reflectance measurements and a chemistry-specific standard curve to calculate the concentration.
The analyte concentration is proportional to the concentration of dye on the film. The amount of dye is quantitated by the measurement of the reflected light from the reagent film using a light emitting diode/photodiode set under the reagent film. Reflectance is read at defined times during the reaction period.
- D. Analyzer Software
The CareSide™ Analyzer is software controlled. The software system utilizes a Real-Time Processor (RTP) and a User Interface Processor (UIP). New software will be provided and installed in the field to add additional tests as they are developed and receive U.S. FDA marketing clearance. The Analyzer is controlled through a touchscreen interface. Results are displayed on the interface screen. Results can also be down-loaded on to a 3-1/2 " diskette or on to a computer via a RS-232 port.
E. System Calibration
Similar to other automated analyzers in commercial distribution, such as the Abaxis Picollo, the CareSide™ Analyzer is factory calibrated. The user is not expected to perform calibration. The Analyzer is calibrated during each test by automatically reading a black and white reflectance standard and making adjustments if necessary.
Each CareSide™ Cartridge bar-code label contains lot-specific coefficients for a polynomial and is scanned by the CareSide™ Analyzer. The observed reflectance is adjusted by inputting it into the polynomial. The patient result is then calculated from the adjusted reflectance using the polynomial describing the master dose - response curve.
The user performs periodic calibration verification and quality control to confirm that the analyzer maintains its calibration over time.
V. Intended Use
Intended Use A.
This product is intended for use with Exigent Diagnostics Cartridges when used by laboratory professionals for the in vitro measurement of various clinical chemistry analytes in human blood.
- B. Indications for Use
This product is indicated for in vitro measurement of various clinical chemistry analytes in human blood.
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VI. Technological Characteristics
- A. Similarities
| CareSide™ Analyzer | Vitros DT 60 II System | |
|---|---|---|
| Intended Use | Intended for the measurementof various analytes usingreflectance photometrymeasurements | Same |
| Indications | For in vitro diagnostic use byprofessional laboratorypersonnel | Same |
| Type | Quantitative | Same |
| Principle ofmethod | Dry film based: chromogenquantitated by reflectancemeasurement | Same |
| Compatiblereagents | CareSide™ Cartridges | Vitros DT Slides |
| Menu | 7 direct and calculated tests(submitted) | 37direct and calculated tests(cleared) |
| Specimen dilution | Not required | Not required |
| Detector | Reflectance | Reflectance |
| Test time | 4 minutes warm-up (on-board) plus up to 6 minutestest time. | 15 minutes warm-up (off-line)plus 5 minutes test time. |
| Sample Type | serum, plasma, whole blood(whole blood. applied sample,plasma test sample)Tests for urine not currentlyavailable | serum, plasmawhole blood not acceptableexcept for hemoglobinUrine for some tests |
| Specimen volume | 85 µl (applied volume) | 10 µl |
| Calibration | Calibration information barcoded on each cartridge.Calibration information maychange with each lot | Run Kodak Ektachem DT IIcalibrators whenever a newslide lot is used or whennecessary |
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B. Differences
| CareSide™ Analyzer | DT 60 II | |
|---|---|---|
| Access | Single patient per platter run | Single or multiple patient |
| Queuing | 6 cartridges | Multiple slides |
| Module | Single | Multiple |
| Software updating | 3-1/2 floppy | EPROM (CDM, CLM) |
| Direct bloodspecimen | Yes, whole blood | No, requires separation ofwhole blood prior to sampleapplication |
| Pipetting | Not required | Required |
| Accuratepipetting | Not required | Required |
| Reagentpre-warming | Not required | Required |
C. Comparative Performance Characteristics
| CareSide™ | DT 60 II | |
|---|---|---|
| Precision | Typical total CV 3.1% to8.5% (4 tests evaluated) | Typical total CV 1.5% to5.2% (4 tests evaluated) |
| Relative Accuracy | Mean difference [Vitros - CareSide™] from method comparison means is test specific (3% for 4 tests evaluated) | |
| Linearity | Correlation coefficient >=0.95 | Not provided |
| Interference | Susceptibility to interference is test specific. | Not provided |
| Detection limit | Test specific. | Not provided |
D. Conclusion
The nonclinical and clinical data provided demonstrate that the CareSide™ Analyzer is as safe, effective, and performs as well as or better than the legally marketed predicate device.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration MAR - 6 1998 2098 Gaither Road Rockville MD 20850
Kenneth B. Asarch, Ph.D. · VP Quality Systems and Requlatory Affairs Exigent Diagnostics Inc. 6100 Bristol Parkway Culver City, California 90230
Re : K980056 CareSide™ Analyzer Regulatory Class: II Product Code: JJF, CDQ, CEK, CIX Dated: December 30, 1997 Received: January 6, 1998
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 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, Druq, and Cosmetic Act (Act). You mav, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਰ 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 In addition, FDA may publish further announcements action. 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.
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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 marret.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitxo 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" a
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
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Exigent Diagnostics, Inc. Page 16
CareSide Analyzer Premarket Notification December 30, 1997
Indications for Use
510(k) Number: Device Name: Indications for use:
rc980056 To be assigned CareSide Analyzer For in vitro diagnostic use by professionals with Exigent Diagnostics Cartridges for the in vitro measurement of various clinical chemistry analytes in human blood.
(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 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (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.