Point-of-Care (PoC) Testing is in vitro diagnostic testing performed at or near the patient rather than in a central laboratory, using compact analyzers or single-use cartridges that return a result in minutes. It supports faster clinical decisions for conditions like infection, glucose management, and cardiac events. PoC systems are regulated as medical devices under FDA and EU IVDR rules.
What is Point-of-Care (PoC) Testing?
Point-of-Care (PoC) Testing covers any in vitro diagnostic (IVD) examination carried out close to the patient: in an emergency department, a clinic exam room, an ambulance, or a pharmacy, instead of being sent to a hospital lab. The defining traits are proximity and speed. A sample goes in, a result comes out, and a clinician acts on it before the patient leaves.
From a device standpoint, PoC testing sits at the intersection of IVD hardware, disposable consumables (cartridges, strips, cassettes), and often a connected reader or reporting layer. Design teams treat it as a system: fluidics or optics for the measurement, embedded software for signal processing, and a user interface built for non-laboratory staff.
Why Point-of-Care (PoC) Testing matters in medical device development
A PoC result often drives an immediate clinical action: starting antibiotics, adjusting insulin, or triggering a cath lab call. If the device gives an inaccurate reading, the harm reaches the patient directly, with no lab review step to catch it. That raises the bar on analytical performance, usability, and manufacturing consistency.
Regulators treat PoC devices as IVD medical devices, not lab accessories. In the US, most fall under FDA’s clinical chemistry and toxicology device rules and need a marketing pathway, typically 510(k) clearance, before sale. EU rules classify them under IVDR 2017/746, where risk class drives how much scrutiny a Notified Body applies. Getting the classification wrong early costs months of rework later.
Cost and time-to-market are also on the line. PoC hardware, cartridge chemistry, and software each carry their own verification burden, and a single missed requirement can force a redesign after tooling is already committed.
How Point-of-Care (PoC) Testing works
A typical PoC test system has a few consistent building blocks, whatever the clinical target:
- Sample interface: a port, strip, or cartridge that accepts blood, saliva, urine, or another specimen with minimal prep.
- Detection method: immunoassay, electrochemical sensing, optical/photonic reading, or microfluidic separation, depending on the analyte.
- Signal processing: embedded software that converts a raw signal into a reportable result, often under IEC 62304 as a medical device software lifecycle.
- Result delivery: an on-device display, printout, or connection to an electronic health record.
Development follows the same design control backbone as any other device: user needs, design inputs, verification, and validation, with risk management under ISO 14971 running throughout. Quality laboratories that support PoC testing, including hospital point-of-care programs, now work to ISO 15189:2022, which folded the older ISO 22870 point-of-care requirements into its Annex A rather than keeping them as a separate standard. Manufacturers build to ISO 13485 for the quality system and, in the US, may pursue a CLIA Waiver by Application if they want the test available outside a certified lab setting. Waiver and clearance are separate decisions; a test can be cleared without being waived.
Common challenges and best practices
Teams new to PoC design often underestimate how differently a test behaves outside a controlled lab. Temperature swings, untrained operators, and inconsistent sample quality all show up in the field even when bench data looks clean. Good practice is to validate with the actual intended users, not lab technicians, since CLIA waiver studies specifically require this.
A second common gap is treating the cartridge or consumable as an afterthought to the reader hardware. In PoC systems, the consumable often carries most of the analytical risk (reagent stability, flow consistency, shelf life), so it needs its own verification plan rather than a footnote in the instrument’s.
Connectivity is another area worth planning early. Sending a result into an EHR or lab information system pulls in interoperability and cybersecurity considerations that are easy to bolt on late and hard to retrofit well.
How SJML helps with Point-of-Care (PoC) Testing
SJML designs and manufactures point-of-care and microfluidics-based IVD platforms end-to-end, spanning mechanical, electronics, embedded software, and systems engineering under one roof. In-house cleanroom manufacturing, PCBA, and consumable production sit alongside process validation, so a PoC device can move from concept through design transfer without changing partners. SJML’s QARA team supports regulatory strategy, international registration, and technical documentation for diagnostic devices, along with post-market surveillance once a product ships.
Talk to SJML’s engineering team →
Frequently asked questions
No. Point-of-care testing describes where a test is performed, near the patient rather than in a lab. CLIA waiver is a separate FDA categorization based on test complexity and risk. A PoC test can be of moderate complexity and restricted to certified lab settings, or waived and usable in a wider range of locations. The two labels answer different questions.
ISO 15189:2022 is the current reference. It absorbed the point-of-care requirements that used to live in the separate ISO 22870:2016 standard, folding them into Annex A. Laboratories previously assessed against ISO 22870 alongside ISO 15189 are transitioning their accreditation scope to the combined 2022 edition as the older standard is withdrawn.
The FDA regulates PoC IVDs as medical devices, most commonly under the clinical chemistry and toxicology device rules in 21 CFR Part 862. Manufacturers typically need 510(k) clearance before marketing. Separately, they can request CLIA categorization and possibly a CLIA Waiver by Application if they want the test usable outside a moderate- or high-complexity lab setting.
Central lab testing runs on high-throughput analyzers operated by trained laboratory staff, usually with a turnaround of hours. Point-of-care testing trades some of that analytical depth for speed and proximity, returning a result in minutes at the bedside or exam room, often operated by clinical staff without laboratory training.
Related terms
- In Vitro Diagnostic (IVD) Device
- CLIA Waiver
- ISO 15189 Accreditation
- Design Verification
- Sample-to-Answer Testing
