(71 days)
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No
The description focuses on automating standard laboratory procedures and data analysis, without mentioning AI or ML technologies.
No.
The device is described as an "in vitro diagnostic" device used for analyzing human and animal specimens, not for treating or rehabilitating patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is used for the in vitro diagnostic processing of human and animal specimens".
No
The device description explicitly states it is a "fully automated microplate analyzer" and lists several physical steps it performs, such as specimen handling, pipetting, washing, incubation, and photometric reading, indicating it includes hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use/Indications for Use: The document repeatedly states that the device is used for "in vitro diagnostic processing of human and animal specimens."
- Performs diagnostic procedures: The device automates steps involved in Immunoenzymatic techniques like EIA and ELISA, which are common diagnostic methods.
- Processes biological specimens: The device handles various human and animal specimens (whole blood, serum, plasma, urine, etc.) for analysis.
- Provides data for diagnosis: The device performs data analysis (quantitative and qualitative) and data management, which are essential for interpreting results and contributing to a diagnosis.
The definition of an IVD is a device intended for use in the collection, preparation, and examination of specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device clearly fits this description by processing specimens and providing analytical data used in diagnostic procedures.
N/A
Intended Use / Indications for Use
The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEM (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as:
- E.I.A. (Enzyme Immuno Assay), and ●
- E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay). ●
The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows:
- Specimen handling and identification, ●
- Specimen pipetting and pre-dilution, .
- Reagent distribution and pipetting. .
- Washing of the microplates. .
- Incubation of the microplates, .
- Photometric reading of the microplates, .
- Data analysis -- both quantitative and qualitative, .
- . Data management - displaying, printing and archiving, and
- Waste management. .
The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows:
- Whole blood, ●
- Serum. .
- . Plasma.
- Urine, .
- Stool. .
- Spinal fluid, .
- . Saliva, and
- Swabs from antigen sites. ●
Product codes
JJE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric 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. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 22 1997
Mr. James SaFranko · Manager, Quality Assurance and Regulatory Affairs BioChem ImmunoSystems, Inc............................... 100 Cascade Drive Allentown, PA 18103-9562
Re : K971761 PersonalLAB™ Automated Microplate Analyzer Regulatory Class: I Product Code: JJE Dated: May 9, 1997 Received: May 12, 1997
Dear Mr. SaFranko:
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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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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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/cdrh/dsmamain.html".
sincerely yours,
Steven Sitman
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
2
510(k) Number (if known):
Device Name: PersonalLAB™ Automated Microplate Analyzer
Indications For Use:
The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as:
- E.I.A. (Enzyme Immuno Assay), and ●
- E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay). ●
The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows:
- Specimen handling and identification, ●
- Specimen pipetting and pre-dilution, .
- Reagent distribution and pipetting. .
- Washing of the microplates. .
- Incubation of the microplates, .
- Photometric reading of the microplates, .
- Data analysis -- both quantitative and qualitative, .
- . Data management - displaying, printing and archiving, and
- Waste management. .
The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows:
- Whole blood, ●
- Serum. .
- . Plasma.
- Urine, .
- Stool. .
- Spinal fluid, .
- . Saliva, and
- Swabs from antigen sites. ●
(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 General Laboratory Devices | |
| 510(k) Number | K971761 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)April 20, 1997
Exhibit 8
DAMA