(22 days)
For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to calculate globulin and albumin/globulin ratio from albumin and globulin results generated on the CareSide Analyzer by professionals to aid in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
The CareSide™ Analyzer uses the Total Protein and Albumin cartridge test results from a single patient sample to determine the globulin concentration and A/G Ratio. Globulin is calculated as the difference between the total protein and albumin concentrations.
The provided text describes the CarcSide™ Globulin and A/G Ratio calculation device, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, the document primarily focuses on:
- 510(k) Summary: This is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
- Device Description: Explaining how Globulin and A/G ratio are calculated from Total Protein and Albumin results using the CareSide™ Analyzer.
- Intended Use and Indications for Use: Defining what the device is for.
- Expected Values (Reference Interval): A study to establish a normal range for healthy individuals.
- FDA Clearance Letter: Confirming that the device has been found substantially equivalent to a predicate device.
Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving their achievement, as this specific information is not present in the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
- This information is not provided in the text. The document focuses on establishing substantial equivalence to a predicate device and defining an expected reference interval for healthy individuals, not on performance against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance:
- Test Set (for establishing Expected Values/Reference Interval):
- Sample Size: 68 ambulatory, healthy adult workers (27 males, 41 females).
- Data Provenance: Not explicitly stated, but implies U.S. data (investigator used CareSide™ Total Protein and CareSide™ Albumin test cartridges). It is a prospective study for establishing reference intervals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the test set in this context is simply the measured Total Protein and Albumin values from healthy individuals using the CareSide™ system itself, which are then used to calculate Globulin and A/G ratio. There's no external expert consensus or pathological assessment described for these reference interval values.
4. Adjudication method for the test set:
- None described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) for calculating biochemical values, not an imaging or interpretive AI device where human readers are directly involved in interpretation that could be "assisted" by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The CarcSide™ Globulin calculation is described as an "in vitro diagnostic product intended for the calculation of globulin" based on results from the Total Protein and Albumin cartridges. The "CareSide™ Analyzer automatically calculates the Globulin measurement and the Albumin to Globulin ratio." This is an algorithmic calculation, and its performance (in terms of accuracy of the calculation and consistency with known biochemical principles) is inherent to its function. The provided document, however, mainly demonstrates substantial equivalence for this calculation method to existing methods, rather than providing an independent standalone accuracy study against a "true" globulin value.
7. The type of ground truth used:
- For establishing the "Expected Values (Reference Interval)," the ground truth is biochemical measurement using the CareSide™ Total Protein and Albumin test cartridges on specimens from a healthy population. The calculated globulin and A/G ratio from these measurements are then presented as a reference interval.
- For the device's substantial equivalence claim, the "ground truth" implicitly relies on the established accuracy and clinical utility of the predicate devices (Vitros TP and Albumin DT Slides) for measuring total protein and albumin, from which globulin is calculated.
8. The sample size for the training set:
- Not explicitly stated. This document is a 510(k) summary, which focuses on substantial equivalence and intended use rather than detailed algorithm development and training data. The calculation itself (Globulin = Total Protein - Albumin) is a fundamental biochemical formula, not typically "trained" in the way a machine learning algorithm would be.
9. How the ground truth for the training set was established:
- Not applicable / not explicitly stated. Given that the device performs a simple calculation (Globulin = Total Protein - Albumin), there isn't a "training set" in the machine learning sense. The accuracy of the calculation relies on the accurate measurement of Total Protein and Albumin by the CareSide™ system, for which substantial equivalence to predicate devices (Vitros TP and Albumin DT Slides) is claimed. The underlying biochemical principles are the "ground truth" for the calculation itself.
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PHONE NO. : 31033867
JAN 2 8 1998
Exigent Diagnostics, Inc. Page 10a
Exigent Diagnostics, Inc.
Kenneth B. Asarch, Pharm.D., Ph.D.
6100 Bristol Parkway
310-338-6767
310-338-6789
January 26, 1998
Culver City, CA 90230
asarchk @ worldnet.att.net
CarcSide™ Globulin and A/G Ratio Premarket Notification revised on January 26, 1998
510(k) Summary: V.
CareSide™ Globulin and A/G Ratio Calculation Safety and Effectiveness
Applicant Information I.
- Applicant Name A.
- Applicant/Manufacturer Address B.
- Telephono Number ਂ
- Contact Person D.
- E. FAX Number
- e-Mail Address F
- Date 510(k) Summary prepared G.
11. Device Information
- Device Name (Trade) A.
- Device Name (Classification) B.
- Device Classification ్ర
- Device Tier D.
E. Snecial controls and performance standards
Substantial Equivalence Claim III.
- General equivaloncy claim A.
The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays. Historically, globulin has been measured directly in a variety of ways, including electrophoretically, nephelometrically, turbidimetrically, and colorimetrically. However, direct measurement is no longer in common use. Rather, commercial in vitro diagnostic systems and clinical laboratories have, for many years, provided clinically useful results by calculating globulin results from albumin and total protein. Calculations of globulin from these dry film and other formats are similarly widely recognized.
Globulin in vitro diagnostic products are already on the U.S. market. These products utilize dry film and other formats. These products utilize the biuret reaction (reaction of protein peptide bonds with cupric ion in alkaline environment),
B. Specific equivalency claim
This CareSide™ Globulin calculation test is substantially cquivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of total protein and albumin on the Vitros DT 60 II.
Johnson and Johnson's Vitros TP and Albumin DT Name of Predicate Device: Eastman Kodak, Slides (formerly Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak's DT 60 II).
Prodicate Device S10K number: Product Code:
K912844/A 75JJP
CareSide™ Globulin and Albumin/Globulin (A/G) Ratin Globulin test system Clinical chemistry panel Globulin test system Regulation Number: 21 CFR 862.1330 Regulatory Class I Tier I . None applicable .
Inc.)
and
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Exigent Diagnostics, Inc. Page 10b
CareSide 14 Globulin and A/G Ratio Premarket Notification revised on January 26, 1998
IV. Device Description
The CareSide™ Analyzer uses the Total Protein and Albumin cartridge test results from a single patient sample to determine the globulin concentration and A/G Ratio. Globulin is calculated as the difference between the total protein and albumin concentrations.
A. Explanation of Device Function
The CareSide™ Globulin is a calculated test hased upon whole blood, plasma or serum results from CareSide™ Total Protein and Albumin cartridges using only the CareSide™ Analyzer [510(k) ponding]. The CareSide™ Globulin is an in vitro diagnostic product intended for the calculation of globulin in human serum, plasma, and whole blood. The principle of the calculation relies upon the following CareSide™ Total Protein and CareSideTM Albumin cartridges test reactions.
Test Reaction Sequences:
Total Protein
Protein + Cupric ion -> purple dye
Albumin
Albumin + Bromocresol green -> Albumin-BCG (Blue)
B. Test Summary
Globulin is a term for a subsct of serum proteins distinguished from the major plasma protein, serum albumin, by their electrophorctic properties. Most globulins have major carbohydrate components. Globulins are categorized by their clectrophoretic properties as, a, B, and y-globulins. a-Globulins include an-globulin and a2-globulin (a2glycoprotein, ceruloplasmin, and prothrombin). B-globulins consist of Bi-lipoproteins, transferrin, and plasminogen. y-globulins, which have molecular weights approximately 150,000, function as antibodies and occur in a very large number of different types. The quantitation of globulin (either indirect calculation or less commonly, direct measurement) is used to sid in the diagnosis of many disease states.
Globulins are elevated infections, most acute and chronic liver diseases, collagen disorders such as theumatoid arthritis and lupus crythematosis, and neoplastic diseases such as multiple myeloma, macroglobulinemia, and leukemia.
Although it is recommended that clinicians evaluate the level of globulin and albumin individually, many physicians additionally request the calculated ratio of albumin to globulin concentration for evaluation.
V. Intended Use
A. Intended Use
The CareSide™ Globulin product is intended for in vitro diagnostic use when used in conjunction with the Exigent Diagnostics CareSide™ Analyzer to calculate globulin and Whon & CareSide™ albuminiglobulin ratio from alhumin and total protein results. Analyzer operator performs both a total protein tost (Product Code: TP) and an albumin test (Product Code: ALB) on a single patient sample, the CarcSide™ Analyzer automatically calculates the Globulin measurement and the Albumin to Globulin ratio Both calculations aid in the diagnosis and treatment of patients with (A/G Ratio). numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of bluad globulins.
B. Indications for Use
This product is indicated for use with patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
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Exigent Diagnostics, Inc. Page 10c
CarcSide™ Clobulin and A/G Ratio Premarket Notification revised on January 26, 1998
Expected Values (Reference Interval) VI.
To determine the following central 95% interval, an on-site investigator used CareSide™ Total Protein and CareSide™ Albumin test carridges on the CareSide™ Analyzer to test specimens from a population of 68 ambulatory, healthy adult workers (males, n=27, mean age 38; females, n= 41, mean age 38):
Globulin 2.7 to 4.2 g/dL 0.9 to 1.6 NG Ratio
This reference interval is similar to the globulin reference interval (2.8 to. 3.8 g/dL) published by Lehninger, 1975. (Lehninger, A.L., Biochemistry, Worth Publishers, p. 831; 1975)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
.IAN 28 1998
Kenneth B. Asarch, Ph.D. . VP Quality Systems and Regulatory Affairs Exigent Diagnostics Inc. 6100 Bristol Parkway Culver City, California 90230
Re : K980055 CareSide™ Globulin Requlatory Class: I Product Code: JGE Dated: December 30, 1997 Received: January 6, 1997
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, 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 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 Requlations, 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 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 requlations.
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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 The FDA described in your 510 (k) premarket notification. 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 the regulation Chercrea, "Morranamy by Tother 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 Bitman
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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Page / of /
510(k) Number (if known): K980055
Device Name:_
Indications For Use:
VII. Indications for Use
510(k) Number: To be assigned Device Name: CareSide Globulin
Indications for use: For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to calculate globulin and albumin/globulin ratio from albumin and globulin results generated on the CareSide Analyzer by professionals to aid in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
(PLEASE DO NOT WRITE BELOW THIS LÌNE-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 | K980055 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
§ 862.1330 Globulin test system.
(a)
Identification. A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.(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.