(63 days)
The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quantitative determination of body fluid constituents using automated spectrophotometric methods.
The AG" Automated Chemistry Analyzer is the latest in a series of automated blood chemistry analyzers for the clinical chemistry laboratory that have become more and more compact as the miniaturization of the technology of the various components has proceeded. The AG" weighs only 37% as much as the currently marketed device, the ASCA Automated Spin Chemistry Analyzer, and has a "footprint" only about one-third as large. The AG" is controlled with a personal computer with a good color monitor, floppy disk drive, hard drive, and printer. The cuvette rotor has a unique self-contained design. Forty cuvettes make up a single cuvette rotor. Each cuvette is made up of a sample shelf and reagent well. The design allows reactions to be completed in the rotor rather than having to be transferred upon mixing, by centrifugal force, to a separate cuvette or reading chamber. The pump uses a rack and pinion drive with a resolution of 3000 steps. The integrated pipettor/dilutor boasts an accuracy of & 1.0% at full stroke and a precision of & 0.05% CV within-run at full stroke. This provides excellent accuracy and precision over a wide range of volumes and speeds.
This is an old 510(k) submission (1997) for a chemistry analyzer. The provided document is a 510(k) summary, which often lacks detailed study results and acceptance criteria as they would be found in the full submission.
Based on the provided text, here's the information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format. It generally states that the results "supported the safety and effectiveness" and "demonstrated that it is substantially equivalent to the predicate device."
| Performance Metric | Acceptance Criteria (Not explicitly stated, inferred from context) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Must meet relevant safety standards | Supported safety |
| EMC | Must meet relevant compatibility standards | Supported safety |
| Precision | Comparable to predicate device or within acceptable limits | Supported effectiveness |
| Accuracy (Standard Samples) | Comparable to predicate device or within acceptable limits | Supported effectiveness |
| Clinical Sample Performance | Comparable to predicate device | Supported effectiveness and substantial equivalence to predicate device |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any of the tests or the data provenance. It only mentions "standard samples" and "clinical samples."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the device is a chemistry analyzer performing quantitative determinations. Ground truth would likely be established by reference methods or comparison to the predicate device, not by expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for a chemistry analyzer's performance testing.
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
This is not applicable. This device is a chemistry analyzer, not an AI-assisted diagnostic imaging device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone chemistry analyzer, meaning its performance is its standalone performance without human input beyond sample loading and general operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The phrase "ground truth" is not explicitly used, but for a chemistry analyzer, the accepted "truth" would come from:
- Reference standards/calibrators: For accuracy testing with "standard samples."
- Predicate device results: For comparison of "clinical samples," where the predicate device's results serve as the comparative truth.
8. The sample size for the training set
This device is not described as utilizing machine learning or AI in the contemporary sense, so there would be no explicit "training set" as understood in that context. Its development would involve engineering and calibration, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as there's no mention of a training set for an AI model. For the development and calibration of the instrument, internal standards and reference materials would have been used.
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K 712469
AUG 2 8 1997
510(k) Summary
Landmark Scientific Inc.
| Common/Classification Name: Centrifugal Chemistry Analyzer for ClinicalUse21 CFR 862.2140, Class I | |
|---|---|
| Sponsor: | Landmark Scientific Inc.110-B Creek Ridge RoadGreensboro, NC 27406 |
| Tel.: (910) 373-0274FAX: (910) 373-1326 | |
| Contact: | Steve Kincaid |
| Prepared: | June 17, 1997 |
A. LEGALLY MARKETED PREDICATE DEVICES
The AG" Automated Chemistry Analyzer System is substantially equivalent to its predicate device currently marketed by Landmark Scientific, the AutoMed Centrifugal Analyzer with Automated Rotor Loader (K781900 and K853453).
B. DEVICE DESCRIPTION
The AG" Automated Chemistry Analyzer is the latest in a series of automated blood chemistry analyzers for the clinical chemistry laboratory that have become more and more compact as the miniaturization of the technology of the various components has proceeded. The AG" weighs only 37% as much as the currently marketed device, the ASCA Automated Spin Chemistry Analyzer, and has a "footprint" only about one-third as large. The AG" is controlled with a personal computer with a good color monitor, floppy disk drive, hard drive, and printer.
The cuvette rotor has a unique self-contained design. Forty cuvettes make up a single cuvette rotor. Each cuvette is made up of a sample shelf and reagent well. The design allows reactions to be completed in the rotor rather than having to be transferred upon mixing, by centrifugal force, to a separate cuvette or reading chamber. The pump uses a rack and pinion drive with a resolution of 3000 steps. The integrated pipettor/dilutor boasts an accuracy of & 1.0% at full stroke and a
000031
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precision of & 0.05% CV within-run at full stroke. This provides excellent accuracy and precision over a wide range of volumes and speeds.
INTENDED USE C.
The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quantitative determination of body fluid constituents using automated spectrophotometric methods.
TECHNOLOGICAL CHARACTERISTICS D.
The AG" System has the same technological characteristics as the predicate device. The AG" is simply a modification with updated hardware and cosmetic changes from the predicate device.
TESTING E.
Landmark Scientific carried out testing to address the following issues:
- (1) electrical safety;
- (2) electromagnetic compatibility;
- (3) precision;
- (4) accuracy of results for standard samples; and
- comparison of performance of the AG" and predicate device on (5) clinical samples.
The results from these tests supported the safety and effectiveness of the AG" System and demonstrated that it is substantially equivalent to the predicate device.
CONCLUSIONS F.
The AG" device has the same intended use as the predicate device. Landmark Scientific Inc. has demonstrated through its performance tests on the AG" System and its comparison of the AG" characteristics with those of the predicate device that the AG" System is substantially equivalent to the predicate device.
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AUG 28 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
T. Whit Athey, Ph.D. Senior Consultant Landmark Scientific, Inc. 110-B Creek Ridge Road Greensboro, North Carolina 27406
Re : K972409 Trade Name: AGI Chemistry Analyzer System Regulatory Class: I Product Code: JJG Dated: June 25, 1997 Received: June 26, 1997
Dear Dr. Athey:
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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 obliqation you miqht 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 market.
If you desire specific advice for your device on our labeling requlation (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
K092409
Device Name: AG" Clinical Chemistry Analyzer_
Indications For Use:
The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quanitiative determination of body fluid constituents using automated spectrophotometric methods.
(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 1. Laboratory Devices
510(k) Number K972409
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 862.2140 Centrifugal chemistry analyzer for clinical use.
(a)
Identification. A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. 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.